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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9698
Device Problems Device Operates Differently Than Expected (2913); Pressure Problem (3012)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Confusion/ Disorientation (2553)
Event Date 12/10/2016
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.
 
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 reporting consumer, concerns a (b)(6) female patient. Medical history included the patient was born without one kidney. Concomitant medication included unspecified medication for pressure and heart. The patient received human insulin (rdna origin) nph (humulin n), cartridge, 40 iu in the morning and 14iu at night, daily, subcutaneous, for unknown treatment reason, beginning on unknown date. The human insulin nph was delivered via humapen luxura champagne (batch number (b)(4)). On (b)(6) 2016, unknown time after starting human insulin nph therapy, patients son bought a new reusable pen, humapen savvio graphite (lot number 1403v07; (b)(4)), but the pen was not applying the medication correctly, it did not have enough pressure to inject the human insulin nph inside patients skin, therefore the patient did not receive the medication on (b)(6) 2016. Due to this, on (b)(6) 2016, patient experienced hypoglycemia, which was considered serious due to intervention required by the company and mental confusion, which was considered serious due to medically significant reasons by the company, and went to the hospital. As corrective treatment for the hypoglycemia patient received glucose at the hospital. It was reported that as soon as patient received the medication, she was recovered from hypoglycemia and mental confusion. No information about exams was provided. No other information about corrective treatment and outcome was provided. It was reported that the patient reused the needles, always performed the calibration after the injections. It was also reported that patient had been using branded insulin and pen for five years and this was the first time that these events happened, but it was not reported which branded insulin and pen patient used. On (b)(6) 2016 human insulin nph was ongoing, but patient was using a syringe to receive the medication. As of (b)(6) 2017, it was provided the patient experienced high creatinine. It was also stated that on (b)(6) 2017 was very hot and the patient had not done anything all day, she was lying down and was feeling very tired even to speak. No additional information was provided. Information regarding corrective treatment and outcome was not provided. The human insulin nph was ongoing. The patient's sons operated the device and were trained by a physician. The patient had used the reported humapen savvio graphite (lot number 1403v07) for 3 days and this device model for unknown time. Return status of the device was unknown. The initial and second reporting consumers did not provide any relatedness opinion. Update 19dec2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Edit 22dec2016: case unlocked to add product complaint number in narrative. Update 26dec2016: additional information was received from the initial reporting consumer on 23dec2016. Added humapen luxura champagne as concomitant device; added lot number of humapen savvio graphite. Updated narrative and corresponding fields accordingly. Update 06-jan-2017: additional information was received on 05-jan-2017 from second reporting consumer. It was added second reporting consumer; added medical history of unilateral renal agenesis; and added non serious adverse events of creatinine increased and tiredness. Correspondent fields and narrative were updated accordingly.
 
Manufacturer Narrative
No further follow up is planned. Evaluation summary: a female patient reported that her humapen savvio device was not injecting insulin properly because the device did not have enough "pressure" to release the insulin. She experienced hypoglycemia, although, the report of hypoglycemia is inconsistent with the alleged malfunction of insulin not being delivered. The device was not returned to the manufacturer for investigation (batch 1403v07, manufactured march 2014). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review for the batch did not identify any atypical findings with respect to dose accuracy or device not working. All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. There is evidence of improper use. The patient reused needles, although this may not be relevant to the event of hypoglycemia.
 
Event Description
Lilly case id: (b)(6). 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 reporting consumer, concerns a (b)(6) black female patient. Medical history included the patient was born without one kidney. Concomitant medication included unspecified medication for pressure and heart. The patient received human insulin (rdna origin) nph (humulin n), cartridge, 40 iu in the morning and 14iu at night, daily, subcutaneous, for unknown treatment reason, beginning on unknown date. The human insulin nph was delivered via humapen luxura champagne (batch number 1210b02). On (b)(6) 2016, unknown time after starting human insulin nph therapy, patients son bought a new reusable pen, humapen savvio graphite (lot number 1403v07; pc#3857002), but the pen was not applying the medication correctly, it did not have enough pressure to inject the human insulin nph inside patients skin, therefore the patient did not receive the medication on 08, 09 and 10dec2016. Due to this, on (b)(6) 2016, patient experienced hypoglycemia, which was considered serious due to intervention required by the company and mental confusion, which was considered serious due to medically significant reasons by the company, and went to the hospital. As corrective treatment for the hypoglycemia patient received glucose at the hospital. It was reported that as soon as patient received the medication, she was recovered from hypoglycemia and mental confusion. No information about exams was provided. No other information about corrective treatment and outcome was provided. It was reported that the patient reused the needles, always performed the calibration after the injections. It was also reported that patient had been using branded insulin and pen for five years and this was the first time that these events happened, but it was not reported which branded insulin and pen patient used. On (b)(6) 2016 human insulin nph was ongoing, but patient was using a syringe to receive the medication. As of (b)(6) 2017, it was provided the patient experienced high creatinine. It was also stated that on (b)(6) 2017 was very hot and the patient had not done anything all day, she was lying down and was feeling very tired even to speak. No additional information was provided. Information regarding corrective treatment and outcome was not provided. The human insulin nph was ongoing. The patient's sons operated the device and were trained by a physician. The patient had used the reported humapen savvio graphite (lot number 1403v07) for 3 days and this device model for unknown time. The device was not returned. The initial and second reporting consumers did not provide any relatedness opinion. Update 19dec2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Edit 22dec2016: case unlocked to add product complaint number in narrative. Update 26dec2016: additional information was received from the initial reporting consumer on 23dec2016. Added humapen luxura champagne as concomitant device; added lot number of humapen savvio graphite. Updated narrative and corresponding fields accordingly. Update 06-jan-2017: additional information was received on 05-jan-2017 from second reporting consumer. It was added second reporting consumer; added medical history of unilateral renal agenesis; and added non serious adverse events of creatinine increased and tiredness. Correspondent fields and narrative were updated accordingly. Edit 23jan2017: case unlocked to perform follow up. Update 31jan2017 additional information received on 30jan2017 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements in describe event or problem. Evaluation summary: a female patient reported that her humapen savvio device was not injecting insulin properly because the device did not have enough "pressure" to release the insulin. She experienced hyperglycemia. The device was not returned to the manufacturer for investigation (batch 1403v07, manufactured march 2014). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review for the batch did not identify any atypical findings with respect to dose accuracy or device not working. All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. There is evidence of improper use. The patient reused needles, which may be relevant to the event of hyperglycemia.
 
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 reporting consumer, concerns a (b)(6) female patient. Medical history included the patient was born without one kidney. Concomitant medication included unspecified medication for pressure and heart. The patient received human insulin (rdna origin) nph (humulin n), cartridge, 40 iu in the morning and 14iu at night, daily, subcutaneous, for unknown treatment reason, beginning on unknown date. The human insulin nph was delivered via humapen luxura champagne (batch number 1210b02). On (b)(6) 2016, unknown time after starting human insulin nph therapy, patients son bought a new reusable pen, humapen savvio graphite (lot number 1403v07; (b)(4)), but the pen was not applying the medication correctly, it did not have enough pressure to inject the human insulin nph inside patients skin, therefore the patient did not receive the medication on (b)(6) 2016. Due to this, on (b)(6) 2016, patient experienced hyperglycemia, which was considered serious due to intervention required by the company and mental confusion, which was considered serious due to medically significant reasons by the company, and went to the hospital. As corrective treatment for the hyperglycemia patient received glucose at the hospital, as reported. It was reported that as soon as patient received the medication, she was recovered from hyperglycemia and mental confusion. No information about exams was provided. No other information about corrective treatment and outcome was provided. It was reported that the patient reused the needles, always performed the calibration after the injections. It was also reported that patient had been using branded insulin and pen for five years and this was the first time that these events happened, but it was not reported which branded insulin and pen patient used. On (b)(6) 2016 human insulin nph was ongoing, but patient was using a syringe to receive the medication. As of (b)(6) 2017, it was provided the patient experienced high creatinine. It was also stated that on (b)(6) 2017 was very hot and the patient had not done anything all day, she was lying down and was feeling very tired even to speak. No additional information was provided. Information regarding corrective treatment and outcome was not provided. The human insulin nph was ongoing. As of (b)(6) 2017 it was reported that the initial consumer reporter did not know the values of hyperglycemia and that patient was not hospitalized due to hyperglycemia. It was also reported that patient used a syringe until she bought another pen, but no information about the new pen was provided. No information about therapy status was provided on (b)(6) 2017, the patients sons operated the device and was trained by a physician. The patient had used the reported humapen savvio graphite (lot number 1403v07) for 3 days and this device model for unknown time. The device was not returned. The initial and second reporting consumers did not provide any relatedness opinion. Update 19dec2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Edit 22dec2016: case unlocked to add product complaint number in narrative. Update 26dec2016: additional information was received from the initial reporting consumer on 23dec2016. Added humapen luxura champagne as concomitant device; added lot number of humapen savvio graphite. Updated narrative and corresponding fields accordingly. Update 06-jan-2017: additional information was received on 05-jan-2017 from second reporting consumer. It was added second reporting consumer; added medical history of unilateral renal agenesis; and added non serious adverse events of creatinine increased and tiredness. Correspondent fields and narrative were updated accordingly. Edit 23jan2017: case unlocked to perform follow up. Update 31jan2017 additional information received on 30jan2017 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 06feb2017: additional information received on 03feb2017 from initial consumer reporter. Changed the serious event of hypoglycemia to hyperglycemia as it was confirmed that on (b)(6) 2016 patient experienced hyperglycemia and not hypoglycemia, updated as reported of the event drug dose omission and event enter date. Added information that patient was not hospitalized and it was unknown the values for hyperglycemia. Added information that patient used a syringe until she bought another pen. Corresponding fields and narrative were updated accordingly. Update 22feb2017. Additional information received 21feb2017 from the product complaint safety database. To the device tabs updated the device specific safety summary (dsss), updated the device medwatch information, and the narrative was updated accordingly.
 
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Brand NameHUMAPEN SAVVIO 3ML (GRAPHITE)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6228423
MDR Text Key64035453
Report Number1819470-2016-00337
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9698
Device Lot Number1403V07
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2014
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: 01/06/2017 Patient Sequence Number: 1
Treatment
HP LUXURA CHAMPAGNE; HUMULIN N
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