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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Stroke/CVA (1770); Fall (1848); Head Injury (1879); Hyperglycemia (1905); Myocardial Infarction (1969); Seizures (2063); Urinary Tract Infection (2120); Visual Impairment (2138); Complaint, Ill-Defined (2331)
Event Date 01/31/2009
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2016-00188, since there is more than one device implicated.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint, with additional information provided by a second consumer, concerns a (b)(6) male patient who was born on (b)(6). The medical history of patient was not provided. The concomitant medications included insulin human isophane, insulin detemir, omeprazole, acetylsalicylic acid, simvastatin and sertraline hydrochloride, all of them for unknown indications. The patient received human insulin (rdna origin) regular (humulin r) cartridge, dose variable (5 iu before breakfast and 5 iu before lunch, however if the glycemia was higher than 300 injected more 3 iu and if it reached 400 injected more 5u), daily, beginning on an unspecified date reported on (b)(6) 2016 as many years ago. The patient took human insulin regular sporadically and started continuous use in (b)(6) 2016. Also the patient received human insulin (rdna origin) nph (humulin n) cartridge, unknown dose, frequency and start date. Both human insulins were administered subcutaneously and for treatment of diabetes. On an unspecified date, unknown if after or prior to the starting of human insulins, the patient was bent (as reported) and due to that his height was less. Information regarding exams, corrective treatment and outcome of this event was not provided. On an unknown date, unknown time after beginning treatment with human insulin regular via humapen luxura champagne (lot number 0803b03) and with human insulin nph via humapen ergo ii (lot number 071d05), the patient had difficulty to see which was aggravating with time due to his advanced age and he underwent a cataract surgery in 2007. The patient did not recover from these events and did not receive corrective treatment for the visual impairment. Moreover, the physician of patient warned him that if his glycemia stayed going up and down, his heart would not hold (as reported) and in 2009 the patient experienced a myocardial infarction which was considered serious by the company due to medically significant reasons, and the patient was hospitalized. As corrective treatment for this event the patient underwent an angioplasty and catheterism and he recovered from it. In (b)(6) 2015, unknown time after the starting of human insulin nph and human insulin regular, the patient fell and had a head injury. Additionally, it was also reported that on the same date the glycemia started to be uncontrolled again and the patient went to the hospital because his glycemia was too high (measure by unspecified device whose result was provided as hi frequently). Information regarding corrective treatment and outcome for these events was not provided. Additionally, in (b)(6) 2015, the patient underwent a tomography exam and the physician decided to discontinue human insulin nph because it was not good, was not lowering (as reported) and replaced by insulin detemir. At that time the patient started to use both reusable pens to deliver human insulin regular. In (b)(6) 2016 the patient had a convulsion and he was hospitalized for 13 days. The patient underwent unspecified exams and the physician discovered that the patient had a sporadically cerebrovascular accident (cva) which was considered serious by the company due to medically significant reason, and due to that the patients glycaemia became uncontrolled again and he started to use a urinary catheter (as reported). The patient did not receive any corrective treatment for the event of cva and it was unknown if he recovered from it. On an unspecified date, reported as before (b)(6) 2016, the patient was very sensitive to human insulin regular and due to that the dose injected was lower than normal but on an unspecified date the required amount of human insulin regular increased. In (b)(6) 2016, unknown time after the starting of human insulin regular, the patient was ill. Information regarding corrective treatment and outcome for the events of drug resistance and general physical health deterioration was not provided. It was also provided that the patient experienced three strong urinary tract infections due to the urinary catheter on unspecified dates, and he was hospitalized in two occasions. In (b)(6) 2016 the patient was hospitalized for 18 days due to one urinary tract infection. As corrective treatment for this event the patient received unspecified antibiotics into vein and he recovered from it. In (b)(6) 2016 the patient was hospitalized again for one week due to urinary tract infection and received an unspecified treatment for this event. Additionally, the patient underwent a surgery to remove the urinary catheter. The patient also had a lobule in the bladder that was blocking his urinary tract and this lobule was removed during the urinary catheter surgery and also underwent enlargement of the urinary canal. The events of bladder lobule and urinary tract obstruction were considered serious by the company due to medically significant reasons. The patient recovered from these events. On an unknown date the two reusable devices presented a problem because after removing the needle from the skin the insulin was still dripping from the devices and due to that the daughter of patient who was a physician thought that her father could not be receiving his entire dose (humapen luxura champagne and humapen ergo ii were associated with (b)(4), respectively). Due to the problem with the devices, the patient stayed one week without insulin since (b)(6) 2016 and he was using human insulin regular from another manufacturer provisionally with a device from another manufacturer in order to continue his treatment. Moreover, it was provided that the patient reused the needles and stored the devices with the needle attached in the refrigerator, along with the in-use insulin cartridges. On (b)(6) 2016 the glycemia reached 250 (measure unit was not provided) at morning, he injected 30 iu of insulin detemir and 5 iu of human insulin regular and at 11:30 am the glycemia was 264 (units and reference range not provided). As of 25jul2016, it was reported that the patient did not have a good hearing since an unspecified date. Information regarding corrective treatment and outcome for this event was not provided. It was unknown if human insulin regular from company would be continued. The daughters of the patient operated the devices and one of them was a physician who trained her sisters. The humapen luxura champagne device model and the reported device were used for five years and the humapen ergo ii device model and the reported device were used for eight years. The return of the devices was expected. The initial reporting consumer stated that the events of myocardial infarction, visual impairment, cataract, fall and head injury were related to the uncontrolled glycemia (blood glucose increased), however, the reporting consumer did not know if the blood glucose increased and myocardial infarction were related to human insulin regular and nph. The initial reporting consumer considered the events of cataract and visual impairment not related to human insulins but considered the events of fall, head injury and blood glucose increased (conflicting information) related to the human insulin nph and human insulin regular. No other opinion of relatedness was provided by the initial or the second reporting consumers. Update 20jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 26jul2016: additional information received on 25jul2016 from a new reporting consumer. Added new reporting consumer and non-serious event of hearing decreased. Narrative and corresponding fields were updated accordingly.
 
Manufacturer Narrative
No further follow up is planned. This report is associated with 1819470-2016-00188, since there is more than one device implicated. Evaluation summary: the daughter of a male patient reported that her father's humapen ergo ii device leaked from the needle after the injection was complete and thought that her father may not be receiving his entire dose. The patient experienced increased blood glucose. The device was not returned to the manufacturer for investigation (batch 0711d05, manufactured november 2007). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review of the batch did not identify any atypical trends with regard to dose accuracy or leaking after injection from device. All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability. The reporter stated the patient had used the device for eight years. The user manual states the humapen ergo ii device has been designed to be used for up to 3 years after first use. There is evidence of improper use. The patient reused needles. Needle reuse may be relevant to the complaint increased blood glucose levels. The patient also used the device beyond its approved use life. It is unknown if this is relevant to the complaint increased blood glucose levels.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint, with additional information provided by a second consumer, concerns a (b)(6) male patient who was born on (b)(6) 1929. The medical history of patient was not provided. The concomitant medications included insulin human isophane, insulin detemir, omeprazole, acetylsalicylic acid, simvastatin and sertraline hydrochloride, all of them for unknown indications. The patient received human insulin (rdna origin) regular (humulin r) cartridge, dose variable (5 iu before breakfast and 5 iu before lunch, however if the glycemia was higher than 300 injected more 3 iu and if it reached 400 injected more 5u), daily, beginning on an unspecified date reported on (b)(6) 2016 as many years ago. The patient took human insulin regular sporadically and started continuous use in (b)(6) 2016. Also the patient received human insulin (rdna origin) nph (humulin n) cartridge, unknown dose, frequency and start date. Both human insulins were administered subcutaneously and for treatment of diabetes. On an unspecified date, unknown if after or prior to the starting of human insulins, the patient was bent (as reported) and due to that his height was less. Information regarding exams, corrective treatment and outcome of this event was not provided. On an unknown date, unknown time after beginning treatment with human insulin regular via humapen luxura champagne (lot number 0803b03) and with human insulin nph via humapen ergo ii (lot number 071d05), the patient had difficulty to see which was aggravating with time due to his advanced age and he underwent a cataract surgery in 2007. The patient did not recover from these events and did not receive corrective treatment for the visual impairment. Moreover, the physician of patient warned him that if his glycemia stayed going up and down, his heart would not hold (as reported) and in 2009 the patient experienced a myocardial infarction which was considered serious by the company due to medically significant reasons, and the patient was hospitalized. As corrective treatment for this event, the patient underwent an angioplasty and catheterism and he recovered from it. In (b)(6) 2015, unknown time after the starting of human insulin nph and human insulin regular, the patient fell and had a head injury. Additionally, it was also reported that on the same date the glycemia started to be uncontrolled again and the patient went to the hospital because his glycemia was too high (measure by unspecified device whose result was provided as hi frequently). Information regarding corrective treatment and outcome for these events was not provided. Additionally, in (b)(6) 2015, the patient underwent a tomography exam and the physician decided to discontinue human insulin nph because it was not good, was not lowering (as reported) and replaced by insulin detemir. At that time the patient started to use both reusable pens to deliver human insulin regular. In (b)(6) 2016, the patient had a convulsion and he was hospitalized for 13 days. The patient underwent unspecified exams and the physician discovered that the patient had a sporadically cerebrovascular accident (cva) which was considered serious by the company due to medically significant reason, and due to that the patients glycaemia became uncontrolled again and he started to use a urinary catheter (as reported). The patient did not receive any corrective treatment for the event of cva and it was unknown if he recovered from it. On an unspecified date, reported as before (b)(6) 2016, the patient was very sensitive to human insulin regular and due to that the dose injected was lower than normal but on an unspecified date the required amount of human insulin regular increased. In (b)(6) 2016, unknown time after the starting of human insulin regular, the patient was ill. Information regarding corrective treatment and outcome for the events of drug resistance and general physical health deterioration was not provided. It was also provided that the patient experienced three strong urinary tract infections due to the urinary catheter on unspecified dates, and he was hospitalized in two occasions. In (b)(6) 2016, the patient was hospitalized for 18 days due to one urinary tract infection. As corrective treatment for this event the patient received unspecified antibiotics into vein and he recovered from it. In (b)(6) 2016, the patient was hospitalized again for one week due to urinary tract infection and received an unspecified treatment for this event. Additionally, the patient underwent a surgery to remove the urinary catheter. The patient also had a lobule in the bladder that was blocking his urinary tract and this lobule was removed during the urinary catheter surgery and also underwent enlargement of the urinary canal. The events of bladder lobule and urinary tract obstruction were considered serious by the company due to medically significant reasons. The patient recovered from these events. On an unknown date, the two reusable devices presented a problem because after removing the needle from the skin the insulin was still dripping from the devices and due to that the daughter of patient who was a physician thought that her father could not be receiving his entire dose (humapen luxura champagne and humapen ergo ii were associated with product complaint numbers (b)(4), respectively). Due to the problem with the devices, the patient stayed one week without insulin since (b)(6) 2016 and he was using human insulin regular from another manufacturer provisionally with a device from another manufacturer in order to continue his treatment. Moreover, it was provided that the patient reused the needles and stored the devices with the needle attached in the refrigerator, along with the in-use insulin cartridges. On (b)(6) 2016, the glycemia reached 250 (measure unit was not provided) at morning, he injected 30 iu of insulin detemir and 5 iu of human insulin regular and at 11:30 am the glycaemia was 264 (units and reference range not provided). As of (b)(6) 2016, it was reported that the patient did not have a good hearing since an unspecified date. Information regarding corrective treatment and outcome for this event was not provided. It was unknown if human insulin regular from company would be continued. The daughters of the patient operated the devices and one of them was a physician who trained her sisters. The humapen luxura champagne device model and the reported device were used for five years and the humapen ergo ii device model and the reported device were used for eight years. The devices were not returned. The initial reporting consumer stated that the events of myocardial infarction, visual impairment, cataract, fall and head injury were related to the uncontrolled glycaemia (blood glucose increased), however, the reporting consumer did not know if the blood glucose increased and myocardial infarction were related to human insulin regular and nph. The initial reporting consumer considered the events of cataract and visual impairment not related to human insulins but considered the events of fall, head injury and blood glucose increased (conflicting information) related to the human insulin nph and human insulin regular. No other opinion of relatedness was provided by the initial or the second reporting consumers. Update 20jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 26jul2016: additional information received on 25jul2016 from a new reporting consumer. Added new reporting consumer and non-serious event of hearing decreased. Narrative and corresponding fields were updated accordingly.
 
Manufacturer Narrative
Narrative field - new, updated and corrected information is referenced within the update statements in describe event or problem. Please refer to update statement dated 21sep2016 in describe event or problem. No further follow up is planned. This report is associated with 1819470-2016-00188, since there is more than one device implicated. Evaluation summary the daughter of a male patient reported that her father's humapen ergo ii device leaked from the needle after the injection was complete and thought that her father may not be receiving his entire dose. The patient experienced increased blood glucose. The investigation of the returned device (batch (b)(4), manufactured november 2007) found that the device met functional requirements and met dose accuracy and glide force specifications. No malfunction was identified. A complaint history review of the batch did not identify any atypical trends with regard to dose accuracy or leaking after injection from device. All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability. The reporter stated the patient had used the device for eight years. The user manual states the humapen ergo ii device has been designed to be used for up to 3 years after first use. There is evidence of improper use. The patient reused needles. Needle reuse may be relevant to the complaint increased blood glucose levels. The patient also used the device beyond its approved use life. It is unknown if this is relevant to the complaint increased blood glucose levels.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint, with additional information provided by a second consumer, concerns a caucasian male patient who was born on (b)(6). The medical history of patient was not provided. The concomitant medications included insulin human isophane, insulin detemir, omeprazole, acetylsalicylic acid, simvastatin and sertraline hydrochloride, all of them for unknown indications. The patient received human insulin (rdna origin) regular (humulin r) cartridge, dose variable (5 iu before breakfast and 5 iu before lunch, however if the glycemia was higher than 300 injected more 3 iu and if it reached 400 injected more 5u), daily, beginning on an unspecified date reported on (b)(6) 2016 as many years ago. The patient took human insulin regular sporadically and started continuous use in (b)(6) 2016. Also the patient received human insulin (rdna origin) nph (humulin n) cartridge, unknown dose, frequency and start date. Both human insulins were administered subcutaneously and for treatment of diabetes. On an unspecified date, unknown if after or prior to the starting of human insulins, the patient was bent (as reported) and due to that his height was less. Information regarding exams, corrective treatment and outcome of this event was not provided. On an unknown date, unknown time after beginning treatment with human insulin regular via humapen luxura champagne (lot number 0803b03) and with human insulin nph via humapen ergo ii (lot number 071d05/(b)(4)), the patient had difficulty to see which was aggravating with time due to his advanced age and he underwent a cataract surgery in 2007. The patient did not recover from these events and did not receive corrective treatment for the visual impairment. Moreover, the physician of patient warned him that if his glycemia stayed going up and down, his heart would not hold (as reported) and in 2009 the patient experienced a myocardial infarction which was considered serious by the company due to medically significant reasons, and the patient was hospitalized. As corrective treatment for this event the patient underwent an angioplasty and catheterism and he recovered from it. In (b)(6) 2015, unknown time after the starting of human insulin nph and human insulin regular, the patient fell and had a head injury. Additionally, it was also reported that on the same date the glycemia started to be uncontrolled again and the patient went to the hospital because his glycemia was too high (measure by unspecified device whose result was provided as hi frequently). Information regarding corrective treatment and outcome for these events was not provided. Additionally, in (b)(6) 2015, the patient underwent a tomography exam and the physician decided to discontinue human insulin nph because it was not good, was not lowering (as reported) and replaced by insulin detemir. At that time the patient started to use both reusable pens to deliver human insulin regular. In (b)(6) 2016 the patient had a convulsion and he was hospitalized for 13 days. The patient underwent unspecified exams and the physician discovered that the patient had a sporadically cerebrovascular accident (cva) which was considered serious by the company due to medically significant reason, and due to that the patients glycaemia became uncontrolled again and he started to use a urinary catheter (as reported). The patient did not receive any corrective treatment for the event of cva and it was unknown if he recovered from it. On an unspecified date, reported as before (b)(6) 2016, the patient was very sensitive to human insulin regular and due to that the dose injected was lower than normal but on an unspecified date the required amount of human insulin regular increased. In (b)(6) 2016, unknown time after the starting of human insulin regular, the patient was ill. Information regarding corrective treatment and outcome for the events of drug resistance and general physical health deterioration was not provided. It was also provided that the patient experienced three strong urinary tract infections due to the urinary catheter on unspecified dates, and he was hospitalized in two occasions. In (b)(6) 2016 the patient was hospitalized for 18 days due to one urinary tract infection. As corrective treatment for this event the patient received unspecified antibiotics into vein and he recovered from it. In (b)(6) 2016 the patient was hospitalized again for one week due to urinary tract infection and received an unspecified treatment for this event. Additionally, the patient underwent a surgery to remove the urinary catheter. The patient also had a lobule in the bladder that was blocking his urinary tract and this lobule was removed during the urinary catheter surgery and also underwent enlargement of the urinary canal. The events of bladder lobule and urinary tract obstruction were considered serious by the company due to medically significant reasons. The patient recovered from these events. On an unknown date the two reusable devices presented a problem because after removing the needle from the skin the insulin was still dripping from the devices and due to that the daughter of patient who was a physician thought that her father could not be receiving his entire dose (humapen luxura champagne and humapen ergo ii were associated with product (b)(4), respectively). Due to the problem with the devices, the patient stayed one week without insulin since (b)(6) 2016 and he was using human insulin regular from another manufacturer provisionally with a device from another manufacturer in order to continue his treatment. Moreover, it was provided that the patient reused the needles and stored the devices with the needle attached in the refrigerator, along with the in-use insulin cartridges. On (b)(6) 2016 the glycemia reached 250 (measure unit was not provided) at morning, he injected 30 iu of insulin detemir and 5 iu of human insulin regular and at 11:30 am the glycaemia was 264 (units and reference range not provided). As of (b)(6) 2016, it was reported that the patient did not have a good hearing since an unspecified date. Information regarding corrective treatment and outcome for this event was not provided. It was unknown if human insulin regular from company would be continued. The daughters of the patient operated the devices and one of them was a physician who trained her sisters. The humapen luxura champagne device model and the reported device were used for five years and the humapen ergo ii device model and the reported device were used for eight years. The humapen luxura champagne device was returned on 16aug2016, and no malfunction was found. The humapen ergo ii device returned on 16aug2016, no malfunction was identified. The initial reporting consumer stated that the events of myocardial infarction, visual impairment, cataract, fall and head injury were related to the uncontrolled glycaemia (blood glucose increased), however, the reporting consumer did not know if the blood glucose increased and myocardial infarction were related to human insulin regular and nph. The initial reporting consumer considered the events of cataract and visual impairment not related to human insulins but considered the events of fall, head injury and blood glucose increased (conflicting information) related to the human insulin nph and human insulin regular. No other opinion of relatedness was provided by the initial or the second reporting consumers. Update 20jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 26jul2016: additional information received on 25jul2016 from a new reporting consumer. Added new reporting consumer and non-serious event of hearing decreased. Narrative and corresponding fields were updated accordingly. Update 19aug2016: additional information received on 19aug2016 from the global product complaint database added the device specific safety summary and manufactured dates of the devices; added the devices were not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 21sep2016. Additional information received 20sep2016 from the product complaint safety database. To the hp ergo ii device tab updated the device specific safety summary (dsss), date of return, changed malfunction to no, updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly. Update 30sep2016: additional information received on 30sep2016 from the global product complaint database added the device specific safety summary, manufactured date, and return date for the humapen luxura; updated the malfunction field to no; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5832964
MDR Text Key51009935
Report Number1819470-2016-00187
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number0711D05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/29/2016 Patient Sequence Number: 1
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