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); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 05/24/2023

Event Type  Injury  

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 adverse events and product complaint (pc), concerns a 13-years-old female patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog 100units/ml) from a cartridge via a reusable device (humapen ergo ii), 35 international units, at an unknown frequency, subcutaneously, for the treatment of type one diabetes mellitus, beginning in 2021(specific date was unknown).Mother of the patient stored the pens at room temperature with needle attached and changed the needle every two or three days (incorrect storage of device).On (b)(6)2023, after starting insulin lispro therapy, she experienced issue with humapen ergo ii.The pen released overdose due to the pen screw defect (pc number (b)(4), lot number 1806d03) which led her to suffer from hypoglycemia.After two hours of having meal her blood glucose was determined at 38 mg/dl (reference range not provided).The event of hypoglycemia was considered as serious by the company due to its medical significance.Information regarding corrective treatment was not provided.Outcome of the events was not recovered.Treatment with insulin lispro treatment was ongoing.The operator of huma pen ergo ii was mother of the patient and her training status was not provided.The general humapen ergo ii device duration of use and suspect humapen ergo ii device duration of use was approximately two years.The status of suspect device was available, and its return was expected.The reporting consumer did not relate the events to insulin lispro therapy but related to the suspect humapen ergo ii device.Update 07-jun-2023: information was received from the initial consumer on 02-jun-2023.No new medically significant information was received and no other changes were made to the case.Edit 07jun2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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.

Manufacturer Narrative

No further follow-up is planned.B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 05jul2023 in the b.5.Field.Evaluation summary the mother of a female patient reported the patient's humapen ergo ii device released an overdose due to a reported pen screw defect.The patient experienced hypoglycemia.Troubleshooting was performed with guidance from a trained professional and the pen released insulin properly, but the reporter is still having issue with the insulin quantity which is released from the pen.The device was not returned for investigation (batch 1806d03, manufactured june 2018).As the device was not returned, the presence of a malfunction could not be confirmed for the issue of insulin quantity released from the pen.Malfunction unknown.A batch review found that the total number of dose accuracy complaints received for the batch is within the established batch threshold, and the batch is not atypical.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.The mother of the patient reported storing the device with the needle attached and changing the needle every two or three days the core instructions for use state to use a new needle for each injection, to remove the needle after every use, and to not store the pen with the needle attached.There is evidence of improper use and storage.The patient reused needles and stored the device with the needle attached.It is not anticipated these misuses contributed to the complaint that the device released an overdose or to event of hypoglycemia.

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 adverse events and product complaint (pc), concerns a 13-years-old female patient of an unknown origin.Medical history was not provided.Concomitant medication included insulin degludec and unspecified vitamins for an unknown indication.The patient received insulin lispro (rdna origin) (humalog 100units/ml) from a cartridge via a reusable device (humapen ergo ii), 35 international units, at an unknown frequency, subcutaneously, for the treatment of type one diabetes mellitus, beginning in 2021(specific date was unknown).Mother of the patient stored the pens at room temperature with needle attached and changed the needle every two or three days (incorrect storage of device).On (b)(6) 2023, after starting insulin lispro therapy, she experienced issue with humapen ergo ii.The pen released overdose due to the pen screw defect (pc number (b)(4), lot number 1806d03) which led her to suffer from hypoglycemia.After two hours of having meal her blood glucose was determined at 38 mg/dl (reference range not provided).The event of hypoglycemia was considered as serious by the company due to its medical significance.Information regarding corrective treatment was not provided.Outcome of the events was not recovered.Treatment with insulin lispro treatment was ongoing.The operator of huma pen ergo ii was mother of the patient and her training status was not provided.The general humapen ergo ii device duration of use and suspect humapen ergo ii device duration of use was approximately two years.The status of suspect device was available, and its return was expected.The reporting consumer did not relate the events to insulin lispro therapy but related to the suspect humapen ergo ii device.Update 07-jun-2023: information was received from the initial consumer on 02-jun-2023.No new medically significant information was received and no other changes were made to the case.Edit 07jun2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21-jun-2023: information was received from the initial consumer on 15-jun-2023.Added a new concomitant drug.No new medically significant information was added to the case.Update 03jul2023: additional information received on 29jun2023 from the global product complaint database.Add device lispro lot number.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; added date of manufacture for the suspect device humapen ergo ii associated with pc (b)(4).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 (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, AZ
• MDR Report Key: 17107387
• MDR Text Key: 317117781
• Report Number: 1819470-2023-00044
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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: MS9557
• Device Lot Number: 1806D03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/27/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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): Other
• Patient Age: 13 YR
• Patient Sex: Female