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

Model Number MS9557

Device Problem Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Overdose (1988); Coma (2417); Missed Dose (2561)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 29jan2020.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen ergo ii device "was impaired because the cartridge started to become empty faster than the usual." she reported possibly receiving an inaccurate dose.The patient experienced abnormal blood glucose and hypoglycemic coma.The device was not returned to the manufacturer for investigation (batch 1710d04, manufactured october 2017).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to dose accuracy.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 provide extensive detail on priming and dosing the pen, and contacting lilly or a healthcare professional if problems are experienced.There is evidence of improper use.The patient continued to use the device with the suspected dose delivery issue.It is unknown if this misuse is relevant to the adverse events.

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), concerns a (b)(6) years-old female patient of unknown origin.Information about medical history and concomitant medications was not provided.The patient received insulin lispro (humalog) cartridge, via humapen ergo ii, unknown dose and frequency, subcutaneously, for diabetes mellitus and the treatment start date was (b)(6) 2018.In (b)(6) 2019, one year after starting the treatment with insulin lispro via humapen ergo ii, the patient possibly missed a dose, no additional information was provided.Also, in (b)(6) 2019, one year after starting the treatment with insulin lispro via humapen ergo ii, the reporting consumer suspected that the humapen ergo ii was impaired, because the cartridge started to become empty faster than the usual (product complaint (b)(4)/lot number 1710d04).The reporting consumer informed that both injection button and injection screw were intact, but the problem continued.It was reported that the patient possibly received an inaccurate dose, her blood glucose level was not stable, also reported as abnormal blood glucose level, since the problem with the device started and sometimes she had hypoglycemic coma.It was mentioned that when she suffered that coma, she did not go to hospital, but after that her health crease professional (hcp) sometimes decreased the insulin dose or increased it according to patients state.It was also reported that the patient was submitted to some lab tests and it showed that she had an accumulation of insulin inside her body (as reported).The events of hypoglycemic coma and abnormal blood glucose level, also reported as blood glucose level not stable, were considered serious by the company due to medically significant reasons.Information about corrective treatment was not provided, the patient was not recovered from the events of missed dose, inaccurate dose, abnormal blood glucose level and infrequent hypoglycemic coma, and the treatment with insulin lispro was ongoing at the time of the initial report.No other information was provided.It was unknown who was the operator of the device and if the operator was trained.The duration of use for this device model and for the reported device were the same, approximately 14 months.The suspect device remained in use and it was available for return.The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer related the treatment with the insulin lispro with the events of hypoglycemic coma and abnormal blood glucose, but did not relate the treatment with the event of inaccurate dose and did not know if the event of missed dose was related with the treatment with the insulin lispro.It was suspect the humapen ergo ii device to be the cause of the cartridge (ampoule) which emptied faster than the usual.No other relatedness opinion was provided.Edit 16jan2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 29jan2020: additional information received on 29jan2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and (b)(6)(eu/(b)(6)) device information, and improper use and storage from no to yes.Added date of manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit 29jan2020: updated medwatch fields for expedited device reporting.No new information added.

• 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): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9649049
• MDR Text Key: 188686756
• Report Number: 1819470-2020-00003
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1710D04
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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): Other
• Patient Age: 14 YR