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

Model Number MS9557

Device Problems Mechanical Problem (1384); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 10/31/2021

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: n/a.This spontaneous case, reported by a consumer, concerns a female patient of unknown age and origin.Medical history and concomitant medication were not provided.The patient received human insulin (humulin r) cartridge, three times a day, before meals (8 dosage form in the morning, 7 dosage form at noon, and 6 dosage form at night),also, she received human insulin (humulin nph) cartridge, once a day, before bedtime (6 dosage form at night), both drugs administered subcutaneously, for diabetes mellitus, beginning on an unknown exact date in 2005.Both human insulins treatments were administrated via humapen ergo ii injection pen since 2005.In 2012, the patient could not press the injection button down, the injection screw could not move, and the insulin was not flowed out.Then, the patient had the reported device replaced for another one of the same type and unknown lot number.In (b)(6) 2021, an approximately eleven years after starting human insulin treatments, the patient was diagnosed with anemia and heart problems.Then, in (b)(6) 2021 the patient was hospitalized due to an unstable blood glucose, anemia, and heart problems.However, an unspecific examinations results showed no heart problems and anemia (unclear if the patient recovered from these events or if she was misdiagnosed at the first time).The patient was discharged of the hospital after 10 days and the outcome event was unknown.Furthermore, patient, following the doctors device, replaced both human insulins for insulin aspart (unknown manufacture) and insulin glargine (unknown manufacture), both treatments via unknown device, dose, route of administration, frequency, indication for use and start date.Moreover, the effect of using insulin aspart and insulin glargine was not good, as reported.No further information about corrective treatment and laboratorial exams was provided.At the time of the initial report, the status of insulin aspart and glargine was unknown and both human insulins treatments were not resumed.It was unknown who operated this device, and it was unknown if the person was trained.The patient had used the first device model for approximately seven years, and the replacement suspect device for approximately nine years (unknown lot).Status of devices was unknown.The reporting consumer did not know if the unstable blood sugar, anemia and heart problems were related to the human insulin treatment.No other information regarding the relatedness was provided.Edit (b)(6) 2022: upon internal review, this case was edited to add a concomitant device of unknown lot for pc only ((b)(4)), no adverse events associated with this device.Narrative and corresponding fields were updated accordingly.Edit 05may2022: upon internal review, this case was unlocked to recalculate assessment due to a system error.Narrative and corresponding fields were updated accordingly.Update 05may2022: additional information received on 05may2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated 05may2022 in the field.No further follow-up is planned.Evaluation summary: the reporter stated the patient used her humapen ergo ii from 2012 through (b)(6) 2021.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 pen was replaced in 2012 and was continued to be used through (b)(6) 2021.The user manual states humapen ergo ii devices are not to be used for more than 3 years after the first use or past the use-by date on the carton.

• 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: 14311680
• MDR Text Key: 294658008
• Report Number: 1819470-2022-00034
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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: 04/14/2022
• 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: Female