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

Model Number MS9557

Device Problem Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated 21dec2020.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii got heavy and stuck, and due to that he could not take his insulin dose for two days.Nothing changed upon changing the needle and the cartridge, and the pharmacist confirmed that the device released insulin but it was hard.The patient experienced diabetic hyperglycemic coma.The device was not returned to the manufacturer for investigation (batch#: 1806d03, manufactured june 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for 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 with high probability.The core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.Based on the patient's narrative, he might have had an additional pen in his possession, but it appears that, if true, the spare pen had not been used.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-years-old (at the time of initial report) male patient of unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via a reusable pen (humapen, unknown device), of unknown dose and frequency, subcutaneously, for diabetes mellitus, beginning approximately in 2005.At the beginning, he took human insulin isophane suspension 70%/human insulin 30% via syringes, but on an unknown date he suffered from leg pain (it was not precise if it was injection site pain or not), so his health care professional (hcp) recommended using the humapen (device type was unknown).On an unknown date in 2019 (one and one and a half year ago), he used humapen (no further details were provided).It was reported that sometimes he suffered from hyperglycemic coma, and was admitted to the hospital several times to manage it.On an unknown date, he had cataract for which he went to the hospital to perform cataract surgery but his blood glucose level was high so he could not perform it at the time but performed it later on.Since (b)(6) 2020, he had been suffering from high blood glucose level (units, values and reference ranges were not provided).He had never spent a night in hospital, he only went for surgery or for hyperglycemic coma and returned home in the same day.On an unknown date in (b)(6) 2020, he started using humapen ergo ii.On (b)(6) 2020, the humapen ergo ii got heavy and stuck (pc no.: (b)(4) and lot no 1806d03) and due to that he could not took his insulin dose for two days, and his blood glucose was high (units, values and reference ranges were not provided).Nothing changed upon changing the needle and the cartridge, and the pharmacist confirmed that the humapen ergo ii released insulin, but it was hard.The event of hyperglycemic coma was considered as serious by the company die to its medical significance.Information regarding further corrective treatment was not provided.He was recovered from the events of hyperglycemic coma and cataract while the outcome of remaining events was unknown.Status of human insulin isophane suspension 70%/human insulin 30% therapy was continued.The patient was the operator of the devices and his training status was not provided.The general and suspect humapen, unknown device duration of use was unknown (started approximately in 2019).The general and suspect humapen ergo ii duration of use was about four months (started approximately in (b)(6) 2020.The action taken with the suspect devices and return status of the humapen was unknown.The suspect humapen ergo ii (lot 1806d03) associated with product complaint#: (b)(4) was not returned to the manufacturer.The initial reporting consumer did not provide the relatedness of events with human insulin isophane suspension 70%/human insulin 30% therapy.The initial reporting consumer related the event of missed dose and blood glucose increased with humapen ergo ii while did not report the relatedness of remaining events with humapen ergo ii.The initial reporting consumer did not report the relatedness of events with humapen, unknown device.Edit from 17dec2020: updated medwatch fields for expedited device reporting.No new information added.Update21dec2020: additional information received on 21dec2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information, and added date of manufacturer for the suspect humapen ergo ii device associated with product complaint#: (b)(4), which was not was not returned to the manufacturer.Corresponding fields, and narrative updated accordingly.

• 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, IN 46285 ; 3174334585
• MDR Report Key: 11058382
• MDR Text Key: 224058073
• Report Number: 1819470-2020-00176
• 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: 12/22/2020

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
• Device Lot Number: 1806D03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• 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: 57 YR