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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Failure to Deliver (2338)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Date 01/31/2020

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.

Event Description

Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by consumer via company representative, who contacted company to report adverse event and product complaint (pc) concerned a (b)(6) years old female patient of (b)(6) nationality. Medical history (complicating disease, allergic history, family medical history) included hypertension. Previous drug adverse reaction and family drug reaction was none. Concomitant medication included acarbose for diabetes mellitus. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via reusable pen (humapen ergo ii), twice daily (11 units in morning and 7 units at night), subcutaneously for the treatment of diabetes mellitus from 1990 or 2000. In summer of 2020, there was human insulin isophane suspension 70%/human insulin 30% leakage out from the humapen ergo ii after injection (pc (b)(4)/ batch number 1410d01). She also suspected medicine liquid was not injected in, due to the issue with the humapen and her blood glucose control was not so good. She experienced hypoglycemia (coma) with blood sugar value was 2-3 and also had high blood glucose with values of 15, 16 (no units and reference ranges were provided). The event of hypoglycemia (coma) was considered serious due to its medical significance. When she developed hypoglycemia (coma), she was sent to the hospital for treatment (because she was unconscious, she did not know what treatment was taken), but she was not hospitalized. As of 09-sep-2020, she was recovering from the events of hypoglycemic coma and high blood glucose. Information regarding corrective treatment and outcome for the remaining event was not provided. Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing. The operator of the humapen ergo ii device and his/her training status was not provided. The humapen ergo ii device model duration of use was 20 years since started approximately in 1990 (conflicting information provided by the reporter with the launch date of the device). The suspect humapen ergo ii duration of use was around three years as it was started in 2017. The use of the humapen ergo ii was ongoing and its return status was not provided. The reporting consumer related the events to the human insulin isophane suspension 70%/human insulin 30% therapy. The reporting consumer related the event of missed dose and blood glucose control was not good to the humapen ergo ii device issue and did not provide a relatedness assessment for the remaining event to humapen ergo ii device. Update 16-sep-2020: additional information received on 09-sep-2020 and 16-sep-2020 from initial reporter. Added events onset for hypoglycemia (coma), blood sugar high and missed dose occurred in summer of 2020, updated to four devices (first second, third and fourth) to concomitant, re-process pc number (b)(4), updated description as reported for missed dose and updated narrative with new information accordingly. Update 21-sep-2020: additional information received on 17-sep-2020 from initial reporter. Updated the treatment received for the event of hypoglycemia (coma) to yes. Updated the narrative with new information. Edit 22sep2020: updated medwatch fields for expedited device reporting and added contact log according. 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): 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: 10568555
• MDR Text Key: 210687928
• Report Number: 1819470-2020-00120
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1410D01
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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: 09/22/2020 Patient Sequence Number: 1