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

Model Number MS9557

Device Problems Excess Flow or Over-Infusion (1311); Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

Lilly case id:(b)(4).This report is associated with product complaint: (b)(4).This solicited case was reported by a consumer who contacted the company to report adverse events and a product complaint (pc) via a patient support program (psp), concerned an adult male patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received human insulin (rdna origin) injections (humulin r) from a cartridge via a reusable pen humapen ergo ii, at an unknown dose, frequency, and route for the treatment of an unknown indication beginning on an unknown date.On an unknown date, while on human insulin therapy, the humapen ergo ii did not give an accurate dose sometimes it released no insulin, and sometimes it released more than the dose recorded, which lead to disturbance in the blood sugar level (exact values, units and reference ranges were unknown) and was hospitalized for disturbance in the blood sugar level ((b)(4)/lot number: unknown).Information regarding the corrective treatment was unknown.He had recovered from the event of blood glucose abnormal, and the outcome of the remaining event was unknown.The status of human insulin treatment was unknown.The operator of the humapen ergo ii was the patient and his training status was not provided.The humapen ergo ii general model duration and suspect duration of use were not reported.The action taken with humapen ergo ii was unknown and the device was not returned to the manufacturer.The initial reporting consumer considered that the event of blood glucose increased was not related and did not report if the remaining event was related to human insulin treatment.The reporting consumer considered that both the events of blood glucose increased and incorrect dose administered were due to product compliant issue of humapen ergo ii.Edit 23feb2022: updated medwatch fields for expedited device reporting.No new information added.Update 10mar2022: additional information received on 09mar2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with unknown lot number of humapen ergo ii.Updated device return status to no (not returned).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

New, updated, and corrected information is referenced within the update statements.Please refer to update statement (s) dated 10mar2022 in the field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device "did not give an accurate dose.Sometimes it released no insulin, and sometimes it released more than the dose recorded." 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 and dose accuracy with high probability.There is no evidence of improper use or storage.

• 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 (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 13720825
• MDR Text Key: 286941993
• Report Number: 1819470-2022-00019
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2022
• 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 Sex: Male