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

Model Number MS9557

Device Problem Crack (1135)

Patient Problem Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a male patient reported that the cartridge holder of his humapen ergo ii device was cracked in (b)(6) 2019.The patient experienced abnormal blood glucose on 29-oct-2019.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The patient reportedly used the device since 2015.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.It is unknown if this misuse is relevant to the event of abnormal blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse event and product complaint (pc), concerned a (b)(6) years-old asian male patient of manchu nationality.Medical history, previous drug adverse reaction, family drug adverse reaction and concomitant medication were none.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100u/ml) from cartridge via reusable pen (humapen ergo ii, blue plastic), thrice daily (12units in morning, 12units in noon and 14units in night), subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2015.In (b)(6) 2019, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the cartridge holder of humapen ergo ii had cracked (b)(4)/ lot number unknown).On an unknown date, he possibly had abnormal blood glucose (no values and reference ranges were provided).On (b)(6) 2019, he was hospitalized for physical examination and blood glucose regulation.No more details regarding treatment and laboratory tests done while hospitalized were provided.As of (b)(6) 2019, he was still in the hospital.Outcome for the event was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The patient was the operator of the humapen ergo ii and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was four years, as it was started in (b)(6) 2015.The suspect device was not returned to the manufacturer.The reporting consumer did not know if the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide a relatedness assessment with its humapen ergo ii device.Update 20nov2019: additional information received on 20nov2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ (b)(6) 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.

• 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: 9427440
• MDR Text Key: 185482496
• Report Number: 1819470-2019-00213
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 11/11/2019
• 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: 66 YR
• Patient Weight: 72