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

Model Number MS9557

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements in please refer to update statement(s) dated 31mar2020.No further follow-up is planned.Evaluation summary: a female patient reported that, on an unknown date, her humapen ergo ii device was dropped and damaged, and the cartridge holder was cracked.On (b)(6) 2020, the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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 core instructions for use states if any of the parts of your humapen ergo ii appear broken or damaged, do not use.The patient reported visual impairment.The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device while visually impaired and continued use of the device despite the cartridge holder being cracked.It is unknown if the misuse is relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) year-old (at the time of initial report) female patient of unknown origin.Medical history included hypertension and allergic to amoxicillin.Family history included her daughter was allergy to alcohol.Concomitant medications included insulin glargine for the treatment of diabetes mellitus.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 iu/ml) from a cartridge, via a reusable humapen ergo ii (blue plastic), three times a day (15 in the morning, 12 at noon, 15 at night), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2019 (last (b)(6)).Since an unknown date she had presbyopia and could not see clearly.On (b)(6) 2020, she was hospitalized today due to high blood glucose.After being hospitalized, she changed the dose to morning: 18, noon: 14, night: 16 following doctor advice (patient with visual impairment was the user of the device- improper use of the device).On an unknown date humapen ergo ii (blue plastic) was dropped and damaged and the cartridge holder was cracked ((b)(4), lot unknown).Information regarding corrective treatment and outcome of the events was not provided.Status of insulin lispro mix 50 was ongoing.The patient was the operator of the reusable humapen ergo ii device and her training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable device duration of use was unknown but started since (b)(6) 2019 (last (b)(6)); approximately 9 months.The suspect device was not returned to the manufacturer.The initial reporting consumer did not provide relatedness assessment between the events and insulin lispro mix 50 drug and humapen ergo ii device.Update 31mar2020: additional information received on 31mar2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(4) (eu/(b)(4)) device information, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 02apr2020: additional information received on 02apr2020 from the global product complaint database.No new information was added.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis
• MDR Report Key: 9943689
• MDR Text Key: 196576262
• Report Number: 1819470-2020-00037
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 04/09/2020

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: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/09/2020
• 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 Age: 55 YR