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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 Insufficient Information (3190)
Patient Problems Cataract (1766); Hearing Impairment (1881); Hyperglycemia (1905); Hypoglycemia (1912); Blurred Vision (2137); Coma (2417)
Event Date 01/31/2016
Event Type  Injury  
Manufacturer Narrative
This is an initial report. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2016-000178 and 1819470-2016-00093, since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer, who contact the company to report and product complaint and an adverse event, concerns a female patient of unknown origin, born on (b)(6) 1938. Medical history included rheumatism since she was (b)(6)-year-old, strong pain on the knee; diabetes type ii, arthritis, arthrosis, osteoporosis (bones were crumbling), clogged vein on the heart and crooked toes due to rheumatism and because of that, she wore wheelchair. Concomitant medication included carvedilol for heart; calcium carbonate + cholecalciferol and cholecalciferol for rheumatism and bones; levothyroxine sodium for thyroid and simvastatin for unknown indication. The patient received human insulin (rdna) nph (humulin n) cartridge, 22 iu in the morning, 14 iu in the afternoon; conflicting information also reported as 20 iu in the morning and 12 iu in the afternoon; and human insulin (rdna) regular (humulin r) cartridge, 6 iu in the morning and 4 iu in the afternoon, both daily, subcutaneously, indicated for diabetes, since an unspecified date, reported as long time ago. It was provided the patient received human insulin nph and regular via humapen luxura hd and humapen savvio and had a third unspecified lilly device color blue, unknown batch number. The patient had been using the devices since starting insulin treatment. Since an unspecified date, unknown time after starting treatment with human insulin nph and human insulin regular, and unknown if via humapen luxura hd, humapen savvio or unspecified lilly device color blue, the patient had been experiencing difficulty hearing. As a corrective measure, the patient wore a hearing aid device, but did not recover of the event. On an unspecified date, the patient experienced cataract. As corrective treatment in 2011, she underwent to a surgery and recovered of cataract and could see very well. The event of cataract was considered serious and medically significant by the company. Nevertheless, it was provided that occasionally the patient experienced blurred vision due to diabetes, when her glycaemia was high; usually around 200, 300 never lower than 150 (units and range not provided). The patient did not receive any corrective treatment for blurred vision and did not recover of it. It was unknown if the patient received any corrective treatment for glycaemia was high and the outcome was not provided. Additionally, the initial reporter consumer stated the patient had already entered in coma four or five times (also reported as more than two times) due to lack of food, since the patient did not eat overnight and her glycaemia dropped down. It was also stated by the reporter that the patient was not sure if she was in use of unspecified lilly device color blue when the comas occurred and that maybe she had changed to another pen. When that happened, a help mobile went to the patient's home and administered glucose into her vein and she was recovered. The event of coma was considered serious and medically significant by the company. Approximately since 2014, the patient started forgetting things. The reporter consumer stated that according to the physician, the patient was forgetting things because of a clogged vein on the neck. Due to that on (b)(6) 2016, she underwent to an unspecified surgical procedure to unclog this vein. It was unknown if the patient received any corrective treatment for the event of patient started forgetting things. The outcome of these events was not provided. The event of clogged vein on the neck was considered serious and medically significant by the company. Furthermore, on unspecified date the patient noticed the humapen luxura hd, batch number (lot 1210g01/(b)(4)) and humapen savvio (lot 1403v04/(b)(4)) were not working, because it was jammed and the insulin was not coming out. No adverse event was reported due to the device problem. The patient did not reuse needles and stored the pen at room temperature. In (b)(6) 2016, the patient experienced another coma and at this time her glycaemia was at 23 (units and range not provided). It was reported the patient's last meal had been around 8 p. M. And the coma happened about 4h or 4h30 a. M. The reporter stated the patient did not realize when she got in coma and that the help mobile was again called to measure her glycaemia and receive glucose. The outcome of the event of coma with glycaemia at 23 was not provided. It was also provided the physician always requested exams, but the patient could not do it, because her glycaemia was always very low and she had to eat something and exams needed fasting. The outcome of the event glycaemia was always very low was not provided. Additionally, between (b)(6) 2016, the patient got flu with catarrh in the throat and nose and she was also presenting cough. No information regarding corrective treatment was provided for the events of flu and cough, and the outcome was unknown. As of (b)(6) 2016, it was reported the patient had been using the unspecified lilly device color blue with human insulin nph and that the numbers had been erased, but it was still possible to use it (b)(4). The treatment with human insulin nph and regular were continued. The patient operated the devices and she was a trained user. It was provided that both devices were new and had been used for a short time. Humapen savvio (b)(4) will not return. Usage concerns resolved and device was reported to be working properly. Humapen luxura hd was not returned therefore an evaluation was not possible. The third unspecified lilly device color blue had been used for a long time (unspecified) and its return is not expected. The reporting consumer related the events of cataract, blurred vision; glycaemia was high, difficulty hearing, heart problem, and coma (first episode) to human insulin nph and regular treatment. No other relatedness opinion was provided. This case is cross referenced to (b)(4). Update 07apr2016: upon review, this case was opened to complete the medwatch fields for regulatory reporting. Edit 12apr2016: case unlocked to add product complaint number only. Update 19apr2016. Additional information received on 18apr2016 from the product complaint safety database. To the device tabs added manufacture dates, the device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch device information and the narrative was updated accordingly. Update 06jul2016: additional information received on (b)(6) 2016 from the initial reporter consumer and on 05jul2016 from the customer service was processed. Added diabetes type ii, arthritis, arthrosis, osteoporosis, clogged vein and unspecified procedure to unclog vein to medical history; deleted the event reported as heart problem and added to medical history as cardiac insufficiency; onset treatment; non-serious event of glycaemia was always very low; conflicting information regarding human insulin nph dosage; non-serious event of flu; non-serious event of cough; serious event of coma with glycaemia at 23 (second episode); third lilly device blue color as suspect (coded as ergo unknown body type) and product compliant; updated device paragraph and causality opinion; added information patient had been using the devices since starting insulin treatment. Narrative rearranged. Regenerated psur comment. Updated narrative and fields with new information accordingly. Edit 06jul2016: the event of patient was forgetting things was downgraded to non-serious and the corrective treatment was updated from yes to unknown; the event of clogged vein on the neck, which had already been outlined in the narrative, was coded in the tab as a serious adverse event. Update 07jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 11jul2016: case unlocked to add product complaint number only. Update 14jul2016: additional information received from initial reporting consumer on 13jul2016. Changed the onset time of difficulty hearing event to include all suspect drugs and devices. Added information about the use of unspecified lilly device color blue when the event of hypoglycemic coma occurred. Recoded the device ergo, unknown body type to humapen, unknown device, and updated eu/ca fields. Narrative and corresponding fields were updated accordingly.
 
Manufacturer Narrative
This report is associated with 1819470-2016-000178 and 1819470-2016-00093, since there is more than one device implicated. Evaluation summary: a female patient reported that the numbers on the "dose selector" of her humapen device were fading. She experienced a hypoglycemic coma. The device was not available to be returned to the manufacturer for investigation (batch unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. While the exact device model was not reported, it was likely a humapen ergo ii based on the color description of the device. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer, who contact the company to report and product complaint and an adverse event, concerns a female patient of unknown origin, born on (b)(6) 1938. Medical history included rheumatism since she was (b)(6), strong pain on the knee; diabetes type ii, arthritis, arthrosis, osteoporosis (bones were crumbling), clogged vein on the heart and crooked toes due to rheumatism and because of that, she wore wheelchair. Concomitant medication included carvedilol for heart; calcium carbonate + colecalciferol and colecalciferol for rheumatism and bones; levothyroxine sodium for thyroid and simvastatin for unknown indication. The patient received human insulin (rdna) nph (humulin n) cartridge, 22 iu in the morning, 14 iu in the afternoon; conflicting information also reported as 20 iu in the morning and 12 iu in the afternoon; and human insulin (rdna) regular (humulin r) cartridge, 6 iu in the morning and 4 iu in the afternoon, both daily, subcutaneously, indicated for diabetes, since an unspecified date, reported as long time ago. It was provided the patient received human insulin nph and regular via humapen luxura hd and humapen savvio and a humapen ergo ii color blue, (unknown lot/pc (b)(4)). The patient had been using the devices since starting insulin treatment. Since an unspecified date, unknown time after starting treatment with human insulin nph and human insulin regular, and unknown if via humapen luxura hd, humapen savvio or unspecified (b)(4) device color blue, the patient had been experiencing difficulty hearing. As a corrective measure, the patient wore a hearing aid device, but did not recover of the event. On an unspecified date, the patient experienced cataract. As corrective treatment in 2011, she underwent to a surgery and recovered of cataract and could see very well. The event of cataract was considered serious and medically significant by the company. Nevertheless, it was provided that occasionally the patient experienced blurred vision due to diabetes, when her glycaemia was high; usually around 200, 300 never lower than 150 (units and range not provided). The patient did not receive any corrective treatment for blurred vision and did not recover of it. It was unknown if the patient received any corrective treatment for glycaemia was high and the outcome was not provided. Additionally, the initial reporter consumer stated the patient had already entered in coma four or five times (also reported as more than two times) due to lack of food, since the patient did not eat overnight and her glycaemia dropped down. It was also stated by the reporter that the patient was not sure if she was in use of unspecified (b)(4) device color blue when the comas occurred and that maybe she had changed to another pen. When that happened, a help mobile went to the patient s home and administered glucose into her vein and she was recovered. The event of coma was considered serious and medically significant by the company. Approximately since 2014, the patient started forgetting things. The reporter consumer stated that according to the physician, the patient was forgetting things because of a clogged vein on the neck. Due to that on (b)(6) 2016, she underwent to an unspecified surgical procedure to unclog this vein. It was unknown if the patient received any corrective treatment for the event of patient started forgetting things. The outcome of these events was not provided. The event of clogged vein on the neck was considered serious and medically significant by the company. Furthermore, on unspecified date the patient noticed the humapen luxura hd, batch number (lot 1210g01/(b)(4)) and humapen savvio (lot 1403v04/(b)(4)) were not working, because it was jammed and the insulin was not coming out. No adverse event was reported due to the device problem. The patient did not reuse needles and stored the pen at room temperature. In (b)(6) 2016, the patient experienced another coma and at this time her glycaemia was at 23 (units and range not provided). It was reported the patient's last meal had been around 8 p. M. And the coma happened about 4h or 4h30 a. M. The reporter stated the patient did not realize when she got in coma and that the help mobile was again called to measure her glycaemia and receive glucose. The outcome of the event of coma with glycaemia at 23 was not provided. It was also provided the physician always requested exams, but the patient could not do it, because her glycaemia was always very low and she had to eat something and exams needed fasting. The outcome of the event glycaemia was always very low was not provided. Additionally, between (b)(6) 2016, the patient got flu with catarrh in the throat and nose and she was also presenting cough. No information regarding corrective treatment was provided for the events of flu and cough, and the outcome was unknown. As of 04jul2016, it was reported the patient had been using the unspecified (b)(4) device color blue with human insulin nph and that the numbers had been erased, but it was still possible to use it ((b)(4)). The treatment with human insulin nph and regular were continued. The patient operated the devices and she was a trained user. It was provided that both devices were new and had been used for a short time. Humapen savvio 1403v04 will not return. Usage concerns resolved and device was reported to be working properly. Humapen luxura hd was not returned therefore an evaluation was not possible. The third unspecified (b)(4) device color blue had been used for a long time (unspecified) and its return is not expected. The reporting consumer related the events of cataract, blurred vision; glycaemia was high, difficulty hearing, heart problem, and coma (first episode) to human insulin nph and regular treatment. No other relatedness opinion was provided. (b)(4). Update 07apr2016: upon review, this case was opened to complete the medwatch fields for regulatory reporting. Edit 12apr2016: case unlocked to add product complaint number only. Update 19apr2016. Additional information received on 18apr2016 from the product complaint safety database. To the device tabs added manufacture dates, the device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch device information and the narrative was updated accordingly. Update 06jul2016: additional information received on 04jul2016 from the initial reporter consumer and on 05jul2016 from the customer service was processed. Added diabetes type ii, arthritis, arthrosis, osteoporosis, clogged vein and unspecified procedure to unclog vein to medical history; deleted the event reported as heart problem and added to medical history as cardiac insufficiency; onset treatment; non-serious event of glycaemia was always very low; conflicting information regarding human insulin nph dosage; non-serious event of flu; non-serious event of cough; serious event of coma with glycaemia at (b)(6) (second episode); third (b)(4) device blue color as suspect (coded as ergo unknown body type) and product compliant; updated device paragraph and causality opinion; added information patient had been using the devices since starting insulin treatment. Narrative rearranged. Regenerated psur comment. Updated narrative and fields with new information accordingly. Edit 06jul2016: the event of patient was forgetting things was downgraded to non-serious and the corrective treatment was updated from yes to unknown; the event of clogged vein on the neck, which had already been outlined in the narrative, was coded in the tab as a serious adverse event. Update 07jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 11jul2016: case unlocked to add product complaint number only. Update 14jul2016: additional information received from initial reporting consumer on 13jul2016. Changed the onset time of difficulty hearing event to include all suspect drugs and devices. Added information about the use of unspecified (b)(4) device color blue when the event of hypoglycemic coma occurred. Recoded the device ergo, unknown body type to humapen, unknown device, and updated eu/ca fields. Narrative and corresponding fields were updated accordingly. Update 26jul2016. Additional information received on 25jul2016 from the product complaint safety database. To the third device tab recoded the unknown device to humapen ergo ii, entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly.
 
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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 Key5811651
MDR Text Key50087591
Report Number1819470-2016-00179
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
Report Date 03/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/21/2016 Patient Sequence Number: 1
Treatment
OSCAL D
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