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

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Date 01/31/2021

Event Type  Injury  

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.

Event Description

(b)(4).This report is associated with product complaint: pending.This solicited case, reported by a consumer via a patient support program, concerns a (b)(6) female patient of unknown origin.Medical history of patient was not provided.Concomitant medication included insulin glargine for diabetes mellitus.The patient received insulin lispro (rdna origin) (humalog) at unknown dose and frequency, subcutaneously via humapen luxura, for the treatment of unspecified diabetes mellitus, beginning on an unspecified date.Since an unspecified date, unknown time after commencing insulin lispro, the patient was admitted around five times in the intensive care unit (icu) due to high blood acetone level.The last admission was on an unknown exact date in (b)(6) 2021.Reportedly, every time patient stayed in the icu for almost five days, but further information was not provided.On an unknown date around (b)(6) 2021, reported as six months before (b)(6) 2021, patient started taking her insulin glargine doses using a humapen ergo, which she got from her uncle.Additionally, on an unknown date, her humapen luxura got broken (lot unknown).On an unspecified date, reported as post (b)(6) 2021, the patient suffered from low blood glucose level, that reached 40 mg/dl (normal range not provided) and she went into diabetic coma, which was considered serious by the company due to its medical significance.Information regarding other laboratory exams and corrective treatment was not provided.As of (b)(6) 2021, insulin lispro therapy was ongoing.It was unknown if patient recovered from the events.It was unknown who operated the devices and if the operator was trained.The duration for use for humapen luxura device model and for this reported suspect device was unknown.The duration for use for humapen ergo device model was unknown and for this reported suspect device was six months.The status and return status of devices was not provided.The reporting consumer did not provide any opinion of relatedness.Edit 14oct2021: updated medwatch fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: ius only; no pc.This solicited case, reported by a consumer via a patient support program, concerns a 14-year-old female patient of unknown origin.Medical history of patient was not provided.Concomitant medication included insulin glargine for diabetes mellitus.The patient received insulin lispro (rdna origin) (humalog) at unknown dose and frequency, subcutaneously, for the treatment of unspecified diabetes mellitus, beginning on an unspecified date.On (b)(6) 2020, patient started receiving insulin lispro via a humapen luxura hd lot number 1801g01.Since an unspecified date, unknown time after commencing insulin lispro, the patient was admitted around five times in the intensive care unit (icu) due to high blood acetone level.The last admission was on an unknown exact date in (b)(6) 2021.Reportedly, every time patient stayed in the icu for almost five days, but further information was not provided.On an unknown date around (b)(6) 2021, reported as six months before (b)(6) 2021, patient started taking her insulin glargine doses using a humapen ergo, which she got from her uncle.On an unspecified date, reported as post (b)(6) 2021, the patient suffered from low blood glucose level, that reached 40 mg/dl (normal range not provided) and she went into diabetic coma, which was considered serious by the company due to its medical significance.Information regarding other laboratory exams and corrective treatment was not provided.Additionally, on (b)(6) 2021, the screw of the humapen luxura hd got broken while inserting the cartridge (product complaint number (b)(4), lot number 1801g01), and then patient started receiving insulin lispro via humalog kwikpen.As of (b)(6) 2021, insulin lispro therapy was ongoing.It was unknown if patient recovered from the events.It was unknown who operated the devices and if the operator was trained.The duration for use for humapen luxura hd device model was unknown, and for this reported suspect device was approximately nine months.The duration for use for humapen ergo device model was unknown and for this reported suspect device was six months.The humapen luxura hd was not being used at the time of report and was not returned to the manufacturer.The status of humapen ergo was not provided.Return status of ergo device was unknown.The reporting consumer did not provide any opinion of relatedness.Edit 14oct2021: updated medwatch fields for expedited device reporting.No new information added.Update 27oct2021: additional information received on 14sep2021 from initial reporter via complaint personnel.Added details of humapen luxura hd (including lot number and specific model) and information regarding product complaint and use of kwikpen formulation.Narrative and corresponding fields were updated accordingly.Update 27oct2021: additional information received on 25oct2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with1801g01 of humapen luxura hd device.Corresponding fields and narrative updated accordingly.Edit 27oct2021: upon internal review on 27oct2021, it was noted humapen luxura hd license was incorrect.Updated to correct license accordingly, no other alterations were made to case.Update 28oct2021: entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields for expedited device reporting.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 28oct2021 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2021-00132 since there is more than one device implicated.Evaluation summary: the reporter stated the patient had been taking her lantus doses using humapen ergo which she received from her uncle 6 months ago.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.It was reported that the patient had been taking her lantus doses using a humapen ergo which she received from her uncle 6 months ago.The user manual states the humapen ergo is for use only with humalog or humulin 3 ml insulin cartridges and not use other brands of insulin cartridges.

• Brand Name: HUMAPEN ERGO
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 12633184
• MDR Text Key: 281072970
• Report Number: 1819470-2021-00133
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR