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

Model Number MS9699

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988); No Code Available (3191)

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

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6) years-old male patient of unknown ethnicity.Medical history included diabetes (since 1994).Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, cartridge), via reusable pen device (humapen savvio gray) which was started sometime in 2017 (for 3 years), at an unknown dose and frequency, subcutaneously, for diabetes, beginning approximately sometime in 2008.On (b)(6) 2020, while on human insulin 70/30 treatment, his humapen savvio gray got impaired and it did not release medication and he was changing the needle with every cartridge (considered as an improper use).On (b)(6) 2020, his humapen savvio gray did not work (pc number: (b)(6) and lot number: 1308v07) and added that his physician also performed troubleshooting on (b)(6) 2020 and confirmed that the pen got impaired and he had to exchange it.And, since malfunction, he suffered from high blood glucose level and became more than 300 mg/dl (reference range not provided) and his physician felt like as if he was not taking his medication (missed doses).Approximately sometime in 2014, he started to suffer from diabetic foot.He was using insulin syringe (not mentioned since when) and since then his blood glucose became normal (values not provided).Since malfunction, he had fatigue using insulin syringe but he added that it felt better when he takes the insulin.On unknown dates, he had suffered from low blood glucose level coma several times but never was been hospitalized as sometimes (as reported), but that last time this happened was when he took his insulin dose with syringe after this humapen savvio gray issue, as he might take overdose by mistake and his blood glucose reached 50 mg/dl (normal reference range not provided) and the coma lasted every time for one hour.Information regarding additional corrective treatment was not provided.He had not recovered from the events of fatigue and diabetic foot while had fully recovered from the remaining events.Human insulin 70/30 treatment was continued.The patient was the operator of the humapen savvio gray device and his training status was not provided.The humapen savvio gray device general model duration of use was not provided and suspect humapen savvio gray device model duration of use was approximately three years.The action taken with humapen savvio gray device was not provided and its return was expected.The reporting consumer did not relate the event of high blood glucose while did not provide any relatedness for the remaining events with human insulin 70/30 treatment.The reporting consumer did not provide any relatedness for the events of low blood glucose and diabetic foot while related the remaining events with its humapen savvio gray device.Edit 23jul2020: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.Edit 23-jul-2020: upon review of information received on 18-jul-2020, device coding updated to humapen savvio gray (previously: humapen savvio graphite) as per cire report information and updated narrative with correct device.No other changes were done.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a 59-years-old male patient of unknown ethnicity.Medical history included diabetes (since 1994).Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, cartridge), via reusable pen device (humapen savvio gray) which was started sometime in 2017 (for 3 years), at an unknown dose and frequency, subcutaneously, for diabetes, beginning approximately sometime in 2008.On (b)(6) 2020, while on human insulin 70/30 treatment, his humapen savvio (gray) got impaired and it did not release medication and he was changing the needle with every cartridge (considered as an improper use).On (b)(6) 2020, his humapen savvio (gray) did not work and added that his physician also performed troubleshooting on (b)(6) -2020 and confirmed that the pen got impaired and he had to exchange it (pc number: (b)(4) and lot number: 1308v07).Since malfunction, he suffered from high blood glucose level and became more than 300 mg/dl (reference range not provided) and his physician felt like as if he was not taking his medication (missed doses).Approximately sometime in 2014, he started to suffer from diabetic foot.He was using insulin syringe (not mentioned since when) and since then his blood glucose became normal (values not provided).Since malfunction, he had fatigue using insulin syringe but he added that it felt better when he takes the insulin.On unknown dates, he had suffered from low blood glucose level coma several times but never was been hospitalized as sometimes (as reported), but that last time this happened was when he took his insulin dose with syringe after this humapen savvio (gray) issue, as he might take overdose by mistake and his blood glucose reached 50 mg/dl (normal reference range not provided) and the coma lasted every time for one hour.Information regarding additional corrective treatment was not provided.He had not recovered from the events of fatigue and diabetic foot while had fully recovered from the remaining events.Human insulin 70/30 treatment was continued.The patient was the operator of the humapen savvio (gray) device and his training status was not provided.The humapen savvio (gray) device general model duration of use was not provided and suspect humapen savvio (gray) (lot number: 1308v07) duration of use was approximately three years.The humapen savvio (gray) device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not relate the event of high blood glucose while did not provide any relatedness for the remaining events with human insulin 70/30 treatment.The reporting consumer did not provide any relatedness for the events of low blood glucose and diabetic foot while related the remaining events with its humapen savvio (gray) device.Edit 23jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 23-jul-2020: upon review of information received on 18-jul-2020, device coding updated to humapen savvio gray (previously: humapen savvio graphite) as per cire report information and updated narrative with correct device.No other changes were done.Update13aug2020: additional information received on 12aug2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen savvio (gray) device associated with product complaint (b)(6), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 13aug2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient that his humapen savvio device "got impaired and did not release the medication." the patient experienced serious events of coma and decreased blood glucose and a non-serious event of increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1308v07, manufactured august 2013).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 findings with respect to device not working issues.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.The patient also reported changing the needle with every cartridge.The core instructions for use states to use a new needle for each injection.There is evidence of improper use and storage.The patient reused needles.This misuse may be relevant to the complaint and the non-serious event of increased blood glucose.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAY)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 10332284
• MDR Text Key: 208971186
• Report Number: 1819470-2020-00093
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9699
• Device Lot Number: 1308V07
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/18/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR