MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Mechanical Problem (1384); No Flow (2991)

Patient Problems Hyperglycemia (1905); 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 spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a male patient of unknown age and origin.Medical history (complication, allergy history, family history), previous drug adverse reaction, family drug reaction and concomitant medication were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100u/ml) from cartridge via reusable device (humapen unknown device, color black-as reported), for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen was not provided.On an unknown date, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he experienced that her blood glucose value was very high (pre-prandial blood glucose value was 15 and postprandial blood glucose value was 25, no units or reference were provided) and diabetes mellitus.In about 2017, he was hospitalised due to diabetic hyperglycemia for 20-30 days.On (b)(6) 2020, the black injection screw of the injection pen could not move, injection button could not be pressed down and medicinal liquid could not flow out (pc (b)(4) / lot number unknown).On an unknown date, he had complications of diabetes which were ear not working, eye not working, haemorrhage at the bottom of the eye.The event of haemorrhage at the bottom of the eye was considered serious due to its medical significance.Information regarding corrective treatment, outcome for the events and status of insulin lispro protamine suspension 75%/insulin lispro 25% therapy was not provided.The operator of the humapen unknown device and his/her training status were not provided.The model humapen unknown device duration of use was not provided.The suspect humapen unknown device duration of use was approximately three years as it was started since 2017.The use of the suspect humapen unknown device was ongoing and its return status was not provided.The reporting consumer did not know if the events were related to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide a relatedness assessment for the events to suspect humapen unknown device.Edit 23jul2020: updated medwatch and (b)(6) and (b)(6) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a male patient of unknown age and origin.Medical history (complication, allergy history, family history), previous drug adverse reaction, family drug reaction and concomitant medication were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100u/ml) from cartridge via reusable device (humapen unknown device, color black-as reported), for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen was not provided.On an unknown date, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he experienced that her blood glucose value was very high (pre-prandial blood glucose value was 15 and postprandial blood glucose value was 25, no units or reference were provided) and diabetes mellitus.In about 2017, he was hospitalised due to diabetic hyperglycemia for 20-30 days.On (b)(6) 2020, the black injection screw of the injection pen could not move, injection button could not be pressed down and medicinal liquid could not flow out ((b)(4)/ lot number unknown).On an unknown date, he had complications of diabetes which were ear not working, eye not working, haemorrhage at the bottom of the eye.The event of haemorrhage at the bottom of the eye was considered serious due to its medical significance.Information regarding corrective treatment, outcome for the events and status of insulin lispro protamine suspension 75%/insulin lispro 25% therapy was not provided.The operator of the humapen unknown device and his/her training status were not provided.The model humapen unknown device duration of use was not provided.The suspect humapen unknown device duration of use was approximately three years as it was started since 2017.The humapen unknown device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the events were related to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide a relatedness assessment for the events to suspect humapen unknown device.Edit 23jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.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 for the humapen unknown device associated with product complaint (b)(4) which was not 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 reported that the injection screw of his humapen (unspecified device type) "could not move, injection button could not be pressed down and medicinal liquid could not flow out." the device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen 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 no evidence of improper use or storage.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 10332447
• MDR Text Key: 208971491
• Report Number: 1819470-2020-00094
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization