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

Model Number UNKNOWN

Device Problems Crack (1135); Fracture (1260)

Patient Problem Hyperglycemia (1905)

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 a consumer with a product complaint, concerns a (b)(6) asian male patient.Medical history of patient included unspecified heart disease.Concomitant medication included metformin for unknown indication.The patient received insulin lispro 25% and insulin npl 75% (humalog mix25) cartridge via humapen (unknown device), 30 units each morning and 30 units each night (twice a day), subcutaneously, for the treatment of diabetes mellitus, beginning around 2014.On unknown date, the cartridge holder of humapen (unknown device) was cracked in almost half (product complaint number: 5951284; unknown lot number).On unknown date, unknown time after starting insulin lispro 25% and insulin npl 75% via reusable pen, the patient experienced high blood glucose (no value provided) and due to that he was hospitalized.Information regarding exams, hospitalization details, corrective treatment and event outcome was not provided.No action was taken with insulin lispro 25% and insulin npl 75% due the event and it was ongoing.It was provided suspect device humapen (unknown device) continued to be used (improper use).Operator of the device and training status were not provided.It was unknown how long the patient used this device model and the reported device was used for approximately three months.The suspect device continued to be used and its return status was unknown.The reporting consumer did not know if the event was related to insulin lispro 25% and insulin npl 75%.Edit 26apr2022: updated medwatch and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 26apr2022: upon internal review it was corrected information regarding improper use of device from no to yes according to initial report from 19apr2022.Corresponding field 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 27may2022 in the b.5.Field.No further follow-up is planned.Evaluation summary.A male patient reported that the cartridge holder of his humapen (unspecified device type) was cracked in almost half.He experienced increased blood glucose.The device was not 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.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient continued to use the device after experiencing the alleged complaint issue.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The patient continued to use the device after experiencing the alleged complaint issue.It is unknown if this misuse is relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer with a product complaint, concerns a 60-year-old asian male patient.Medical history of patient included unspecified heart disease.Concomitant medication included metformin for unknown indication.The patient received insulin lispro 25% and insulin npl 75% (humalog mix25) cartridge via humapen (unknown device), 30 units each morning and 30 units each night (twice a day), subcutaneously, for the treatment of diabetes mellitus, beginning around 2014.On unknown date, the cartridge holder of humapen (unknown device) was cracked in almost half (product complaint number: (b)(4); unknown lot number).On unknown date, unknown time after starting insulin lispro 25% and insulin npl 75% via reusable pen, the patient experienced high blood glucose (no value provided) and due to that he was hospitalized.Information regarding exams, hospitalization details, corrective treatment and event outcome was not provided.No action was taken with insulin lispro 25% and insulin npl 75% due the event and it was ongoing.It was provided suspect device humapen (unknown device) continued to be used (improper use).Operator of the device and training status were not provided.It was unknown how long the patient used this device model and the reported device was used for approximately three months.The suspect device continued to be used and was not returned to manufacturer for investigation.The reporting consumer did not know if the event was related to insulin lispro 25% and insulin npl 75%.Edit 26apr2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 26apr2022: upon internal review it was corrected information regarding improper use of device from no to yes according to initial report from 19apr2022.Corresponding field and narrative updated accordingly.Update 27may2022: additional information received on 25may2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen (unknown) device associated with (b)(4), lot unknown.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN UNKNOWN DEVICE
• Type of Device: FOR 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 14270076
• MDR Text Key: 290672286
• Report Number: 1819470-2022-00033
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/01/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian