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

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.This report is associated with 1819470-2019-00205 since there is more than one device implicated.Evaluation summary: on (b)(6) 2019, a male patient reported that the "spring" of his humapen ergo ii device had a malfunction and the insulin could not be injected normally.The patient experienced non-serious increased blood glucose.The device was not returned for investigation (batch unknown).With the guidance of a trained professional; troubleshooting was performed and the issue was resolved.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 patient reportedly used the device for ten years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.This is not likely relevant to the event since the device was reported to function normally after troubleshooting.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned an approximately (b)(6)-year-old male patient of unknown origin.Medical history include that he used insulin lispro protamine suspension 75% /insulin lispro 25% for the treatment of diabetes mellitus and stopped on an unknown date in 2014.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50 3ml: 300 iu/unknown formulation), via a reusable pen (humapen ergo ii two tone blue 3 ml) and (humapen luxura, burgundy 3 ml), at unknown doses, dosing frequencies, subcutaneously, for the treatment of diabetes mellitus, beginning on unknown dates in 2014.On unknown dates in 2017, he had been hospitalized for several times for high blood glucose (values, units and normal reference ranges not provided).On (b)(6) 2019, due to second time experiencing high blood sugar (units and reference range were not provided), he went to outpatient of hospital for examination but had not been hospitalized.On (b)(6) 2019, it was reported that now (exact onset date not provided) the spring (of the humapen ergo ii and humapen luxura, burgundy) was broken and the insulin could not be injected normally (pc: (b)(4); lot number: unknown) and (pc: (b)(4); lot number: unknown).Information regarding corrective treatment was not provided.Outcome of the events blood sugar increased and missed dose was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was continued.The operator of humapen luxura (burgundy) and humapen ergo ii was the patient and his training status was not provided.The humapen luxura (burgundy) and humapen ergo ii general model durations were not provided and the suspect devices model durations of use was more than 10 years.Humapen luxura (burgundy) and humapen ergo ii devices were continued and were not returned to the manufacturer.The initial reporting consumer did not provide the relatedness assessment of the events of blood sugar increased (both episodes) and missed dose with insulin lispro protamine suspension 50%/insulin lispro 50% drug.The initial reporting consumer did not provide the relatedness assessment of the event blood sugar increased (both episodes) with suspect humapen ergo ii device and suspect humapen luxura (burgundy) device; and related the event of missed dose with suspect humapen ergo ii device and suspect humapen luxura (burgundy) device.Update 25-oct-2019: information received from the initial reporting consumer via psp on 21-oct-2019.Previously reported information related to hospitalization was received.Update the start date and stop date of historical drug.No other clinically significant information was added to the case.Updated the narrative accordingly.Update 04-nov-2019: information received from the initial reporting consumer via psp on 30-oct-2019.This case was upgraded to serious after addition of serious event of high blood glucose (in 2017) and one lab test for high blood glucose.Updated; patient age, causality statement, eu(b)(6) fields, device element and narrative with new information.Edit 06nov2019: updated medwatch fields for expedited device reporting.No new information added.Update 18nov2019: additional information received on 18nov2019 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, malfunction from unknown to no, and device return status to not returned to manufacturer for pc (b)(4) associated with an unknown lot of a humapen ergo ii device and pc (b)(4) associated with an unknown lot of an humapen luxura (burgundy) device.Updated description as reported on non serious event from high blood pressure to high blood glucose.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): 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: 9386400
• MDR Text Key: 188002706
• Report Number: 1819470-2019-00206
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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
• Date Manufacturer Received: 10/30/2019
• 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: 62 YR