MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated 16jul2021.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device "was difficult to be pressed down and it was not good to be used as the workmanship was rough." the patient experienced abnormal blood glucose.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 ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerns a male patient of unknown age and origin.No medical history and concomitant medication were provided.The patient received insulin lispro (humalog) via humapen ergo ii at unknown dose, frequency, route of administration and start date, for diabetes mellitus.At unknown date and unknown period since beginning insulin lispro via humapen ergo ii, the patient was hospitalized to regulate his blood glucose.Additionally, it was reported that the humapen was difficult to be pressed down and it was not good to be used as the workmanship was rough (lot number unknown; pc number (b)(4)).Information regarding outcome, corrective treatment and laboratorial exams were not provided.It was unknown if insulin lispro was continued or not.Since reporter declined to be contacted and health care professional (hcp) contact was unknown, follow up was not possible.The operator of device and the training status were not provided.It was unknown how long the device model and suspect device had been used.The device was bought from the internet.The status of use was unknown.The humapen ergo ii device (unknown lot) associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the event was related to insulin lispro.Update 05jul2021: additional information received on 01jul2021 from the reporting consumer was processed within initial case entry.Update (b)(6) 2021: additional information received on 15jul2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european (b)(6) device information for the humapen ergo ii device associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• 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
• MDR Report Key: 12256200
• MDR Text Key: 268075858
• Report Number: 1819470-2021-00091
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• 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