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

Model Number MS9557

Device Problems Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse events, concerned a 2-year-old (at the time of the initial report) female patient of an unknown origin.Medical history and concomitant medications were not reported.The patient received insulin lispro (rdna origin) cartridge (humapen ergo ii) via reusable pen, 3iu, twice a day, subcutaneously for the treatment of type 1 diabetes beginning on an unknown date in 2021.On an unknown date in (b)(6) 2023, the pen did not release accurate doses which led to increase in the patients blood glucose level which reached up to 500mg/dl as per the physician assessment (pc number, (b)(4); lot number, 1709d02).On an unknown date, while on insulin lispro therapy, she was still suffering from disturbance in blood glucose level due to a possible device defect, the pens screw is defected as it could not push the cartridge to release insulin which led to release inaccurate insulin doses, sometimes she experienced hyperglycemia that reached up to 500mg/dl, and sometimes hypoglycemia that reached 39mg/dl, reference ranges were not provided.When she needed any corrective doses, the pen needed to be adjusted on one extra dose, but it caused elevation in blood glucose levels and seizures, as the delivered dose was inaccurate.The event of seizure, hypoglycemia and hyperglycemia were considered serious by the company due to its medically significance.The pen was storage in refrigerator.Information regarding corrective treatment was not reported.Outcome of the events of blood glucose increased and hyperglycemia was not recovered, outcome of the remaining events was not provided.The status of insulin lispro therapy was ongoing.The operator of the device was patient family member, and his/her training status was not provided.The humapen ergo ii device model duration of use was two years and suspect duration of use was not provided.Humapen ergo ii device status was available for return, if device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer did not provide an opinion of relatedness between the event of seizure and the insulin lispro therapy, but she did not relate the remaining events with the insulin lispro.The reporting consumer related the events with inaccurate insulin dose delivered by humapen ergo ii.Update : 03-jul-2023: no new medically significant information received on 27-jun-2023 via rcp.Pc number received processed accordingly and no new information added to the case.Update : 19-jul-2023: information was received from the initial reporting consumer on 17-jul-2023.Added the events of hypoglycemia, hyperglycemia and seizures.Updated narrative accordingly.Edit: 02aug2023: upon internal review, changed improper use from no to yes and considered follow-up information as significant for device.Update: 03aug2023: additional information received on 28jul2023 from the global product complaint database.Entered the device specific safety summary (dsss), the medwatch and european and canadian (eu/ca) device fields; and added the date of manufacture for the suspect humapen ergo ii device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 09-aug-2023: upon internal discussion, the event of hyperglycemia was updated from non-serious to serious for other med sig.Updated narrative accordingly.Edit: 10-aug-2023: upon internal review, the serious event of hyperglycemia was correctly assessed with all labels.Edit: 11-aug-2023: upon internal review of the information received on 17-jul-2023.Follow up row was added for a med sig edit performed on 10-aug-2023.And the case was routed to medical review.No further changes were made.Edit: 17aug2023: upon internal review, case type was changed from solicited to spontaneous in narrative.No new clinical information was received.

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(s) dated (b)(6) 2023 in the b.5.Field.No further follow-up is planned.Evaluation summary a patient's family reported her humapen ergo ii device did not release accurate doses and the "pen's screw is defected as it could not push the cartridge to release insulin." the patient experienced seizure and hypoglycemia.The device was not returned to the manufacturer for investigation (batch 1709d02, manufactured september 2017).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.Troubleshooting was performed and the device released insulin, but the dose was considered to be inaccurate by the reporter and the physician.A batch threshold review did not identify any atypical findings regarding dose accuracy issues.The total number of dose accuracy complaints received for the batch is within the established batch threshold, and the batch is not atypical.A complaint history review of the batch did not identify any atypical findings with regard to pen jam issues.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 user reported storing the device in the refrigerator.The core instructions for use state to not store the device in a refrigerator.There is evidence of improper use.The user stored the device in the refrigerator.It is unknown if this misuse is relevant to the complaint issue or the events of seizure and hypoglycemia.

• 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: catherine cassidy ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 17638227
• MDR Text Key: 322144680
• Report Number: 1819470-2023-00053
• 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
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1709D02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2017
• 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: 2 YR
• Patient Sex: Female