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

Device Problem Mechanical Problem (1384)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.Please refer to statement dated 13feb2021 in.No further follow up is planned.This report is associated with 1819470-2021-00029 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 to report adverse events, concerned a (b)(6) asian female patient.Medical history included hypertension.Concomitant medications were not provided.The patient also received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25) from a cartridge via humapen ergo ii device and an unknown humapen device, morning 12 units and night 10 units, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2000.On an unknown date while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the postprandial blood glucose was generally 7-8, 8-9.On an unknown date in (b)(6) 2021, the humapen ergo ii device (pc number: 5461106; batch lot: 0912d02) and an unknown humapen device (pc number: 5461104; batch lot: unknown) had malfunctioned, the black injection screw of the humapen did not move, the injection button could be pushed down, the dose was inaccurate.On (b)(6) 2021, she was in hospital because the blood glucose was high to 15-16, 16, sometimes 20-30.Outcome for the events and information regarding corrective treatment were not reported.Insulin lispro protamine suspension 75%/insulin lispro 25% status was ongoing.The operator of the humapen ergo ii device and an unknown humapen device and her training status were unknown.The unknown humapen device, general device use and the suspect unknown humapen device use was not provided.The humapen ergo ii device general device use and the suspect humapen ergo ii device use was around one year.The action taken with the suspect humapen ergo ii device and an unknown humapen device was unknown and the suspect device were no returned to manufacturer.The reporting consumer did not know the relatedness assessment between the events with insulin lispro protamine suspension 75%/insulin lispro 25% therapy or with the humapen ergo ii device and an unknown humapen device.The event of inaccurate dose was associated with the malfunction of humapen ergo ii device and an unknown humapen device.Edit 09-feb-2021: upon review of initial information received on (b)(6) 2021 updated conding of suspect devices to humapen ergo ii and humapen unknown.Update 13feb2021: additional information received on 05feb2021 from the global product complaint database.Reprocessed pc 5461104 and 5461106.Entered the device specific safety summary (dsss), updated the medwatch and european and (b)(6) (eu/(b)(6)) device fields, and added the date of manufacture for the suspect device associated with pc 5461106.Entered the device specific safety summary (dsss) and updated the medwatch and european and (b)(6) (eu/(b)(6)) device fields for the suspect device associated with pc 5461104.Corresponding fields and narrative updated accordingly.Edit 16feb2021: updated medwatch fields for expedited device reporting.No new information added.Edit 17feb2021: updated medwatch fields for expedited device reporting.No new information added.

• 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 Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 11338101
• MDR Text Key: 239252075
• Report Number: 1819470-2021-00028
• 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
• Report Date: 02/17/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/17/2021
• 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: 67 YR
• Patient Weight: 61