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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This solicited retrospective maternal case, reported by a consumer via a patient support program (psp), and with additional information from the initial reporter via psp, concerned a 43-year-old (at the time of the initial report) female patient of unknown origin.Medical history included current pregnancy being associated with advanced maternal age, twin pregnancy (first) that led a miscarriage in 2016 due to blood clotting, second pregnancy associated with advanced maternal age in 2017 and baby born in (b)(6) 2018, latent autoimmune diabetes in adults (lada) and diabetes.Historical drugs included insulin aspart, insulin detemir and metformin, all for unknown indication.No high-risk behaviors were provided.Concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) injections (humulin n) and human insulin (rdna origin) injections (humulin r) from cartridges via reusable device (humapen ergo ii), both for the treatment of diabetes, beginning approximately in 2018 (conflicting information provided, since it was also reported that she started both suspect drugs on an unspecified date, after miscarriage).The date of her last menstrual period and estimated due date (edd) was not provided.On an unknown date approximately in 2021, while on human insulin and human insulin isophane suspension therapies, she became pregnant (third pregnancy).No prenatal tests were reported.She did not have problems during her pregnancy.On an unknown date in 2021, she gave birth to an infant (gender not reported).On an unspecified date after two months of breastfeeding, her glucose risen to 700 (units and reference ranges were not provided), therefore her milk was discontinued.On an unspecified date, she was hospitalized for one week due to the event to monitor her glucose and for investigating the cause of the event.On an unspecified date, while she was in the hospital, her blood glucose spikes suddenly (values and reference ranges were not provided) and no reason could be found.Human insulin and human insulin isophane suspension therapies were continued up for three to four months after birth because when she switched to other insulins, she did not feel well.Information regarding hospitalization dates, laboratory examination findings, corrective treatments and outcome of the remaining events was not provided.On an unknown date in 2021, she gave birth to an infant (gender not reported) at the gestational age of 36 weeks via a cesarian section as her previous birth was also a cesarian.Apgar score, height, weight and circumference of baby was not provided.The infant was breastfed right after the birth.Human insulin and human insulin isophane suspension therapies were continued up until the end of pregnancy.The infant stayed in intensive care unit for 10 days after the birth because the baby was breathing rapidly.The operator of the humapen ergo ii and his/her training status were not provided.The suspect humapen ergo ii with an unknown lot duration of use was eight years (improper use) and the humapen ergo ii with lot 1709d01 duration of use was approximately 6 years.The action taken with both humapens ergo ii was not provided and not returned to the manufacturer.The reporting consumer did not provide an opinion of relatedness between the events and human insulin and human insulin isophane suspension therapies nor with the two suspects humapens ergo ii.The reporter did not provide an opinion of causality for the exposure events; the exposure events were entered for tracking purposes.The case was cross-referenced with the cases: (b)(6) (same patient) and with (b)(6) (infant case).Update 17-apr-2023: additional information received on 12-apr-2023 from the initial consumer reporter via psp which upgraded the case to serious.Added miscarriage and blood clotting as medical history; insulin aspart, insulin detemir and metformin as historical drugs, pregnancy details, stop date for the maternal exposure during pregnancy, serious event of blood glucose increase and, non-serious event of blood glucose increase and maternal exposure during breast feeding.The suspect device was upgraded to suspect.Updated narrative with new information.Edit 09-may-2023: upon review of information received on 12-apr-2023, added a second suspect device and the opinion of relatedness between the events and the suspect devices.Amended the improper use or storage from no to yes for the first device.Amended narrative accordingly.Update 10may2023: additional information received on 10may2023 from the global product complaint database.Entered the device specific safety summaries (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for device with unknown lot and lot 1709d01.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

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.This report is associated with 1819470-2023-00031 since there is more than one device implicated.Evaluation summary the patient stated the humapen ergo ii was used for approximately six years (based on lot number 1709d01).There was no product complaint for the device, and the device was not returned for investigation.There was evidence of improper use of the device.The patient used the humapen ii for approximately six years.The humapen ergo ii user manual states to not use the pen for more than three years after the first use.

• 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
• MDR Report Key: 16908492
• MDR Text Key: 314972362
• Report Number: 1819470-2023-00036
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1709D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• 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): Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female