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

Model Number MS9557

Device Problems Break (1069); Fluid Leak (1250)

Patient Problem Hyperglycemia (1905)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2020-00135 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6)-years-old (at the time of initial report) asian female patient of (b)(6) nationality. Medical history included lung cancer. Concomitant medications included metformin hydrochloride, glimepiride and acarbose; all taken for diabetes mellitus. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, 100u/ml) from a cartridge, via blue color reusable pen device (humapen ergo ii) which was started approximately sometime in 2005 (reported as 10-20 years ago), at 14 units in morning and 18 units at night, twice daily, subcutaneously, for diabetes mellitus, beginning on an unknown date. The patient also received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 100u/ml) from a cartridge, via blue color reusable pen device (humapen ergo ii), at 10 units in morning and 14 units at night, twice daily, subcutaneously, for diabetes mellitus, beginning on an unknown date. Sometime in (b)(6) 2020, while on human insulin 70/30 and insulin lispro 75/25 treatments that were alternatively used, her blood glucose was not too good (pre-prandial blood glucose value was 10-20, postprandial was 23, units and range not provided) due to which she was hospitalized for regulating the blood glucose sometime in (b)(6) 2020 for half a month (15 days) and was discharged in the same month. Sometime in (b)(6) 2020, her humapen ergo ii had liquid leakage (pc: (b)(4); lot: unknown) due to which it was discontinued and the long duration of approximately 15 years of usage was considered as an improper use. ,and a new humapen ergo ii was started and was used until the time of report. Sometime in 2020, few months ago, the cartridge holder of the second humapen ergo ii was cracked (pc: (b)(4); lot: 1810d04). Information regarding additional corrective treatment and exact hospitalization details was not provided. The outcome for the event was not reported. Human insulin 70/30 and insulin lispro 75/25 treatments were continued. The operator of the humapen ergo ii devices and his/her training status was not provided. The first humapen ergo ii device general model duration and suspect humapen ergo ii device model duration of use approximately 15 years (which was started sometime 10-20 years ago) while the second humapen ergo ii device general model duration and suspect humapen ergo ii device model duration of use approximately was 15 days (started sometime in (b)(6) 2020). The first humapen ergo ii was discontinued sometime in (b)(6) 2020 and the second humapen ergo ii was continued. The first humapen ergo ii device (unknown lot) associated with (b)(4) was not returned to the manufacturer. The second humapen ergo ii device (lot 1810d04) associated with (b)(4) was returned to the manufacturer. The reporting consumer did not provide any relatedness for the event with human insulin 70/30 and insulin lispro 75/25 treatments and its humapen ergo ii devices. Update 02-oct-2020: information was received on 27-sep-2020 from the affiliate provided the product complaint (pc) number (b)(4) and pc was processed accordingly. Updated status of second humapen ergo ii device in respect to product complaint (cartridge holder cracked) and narrative with new information. Edit 05oct2020: updated medwatch fields for expedited device reporting. No new information added. Update 12oct2020: additional information received on 11oct2020 from global product complaint database. Changed the lot number from unknown to 1810d04 for product complaint (b)(4) relating to the humapen ergo ii device. Corresponding fields and narrative updated accordingly. Update 14oct2020: additional information received on 14oct2020 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information for the humapen ergo ii device (unknown lot) associated with (b)(4) which was not returned to the manufacturer. Updated device return status to returned to manufacturer and added date returned to manufacturer for the humapen ergo ii device (lot 1810d04) associated with (b)(4). 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: 10707568
• MDR Text Key: 216682446
• Report Number: 1819470-2020-00134
• 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,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1810D04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/20/2020 Patient Sequence Number: 1