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

Device Problems Break (1069); Material Discolored (1170)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.Evaluation summary: the reporter said the patient bought a cartridges pack of insulin lispro that was different from any other pack she previously bought.The insulin lispro cartridge color was white instead of maroon and the insulin itself was not clear.There was not product complaint for the device, and the device was not returned for investigation.There was evidence of improper use of the device.The patient administered a new type of insulin cartridge that was different from any other pack she previously bought and the cartridge color was white instead of marron and the insulin itself was not clear.The user manual states to always check he appearance of the insulin through the cartridge holder and be sure the pen contains the correct insulin cartridge.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine used for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml), through cartridge via a reusable pen (humapen ergo unknown body type), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.Dose and frequency were unknown.On an unknown date, while on insulin lispro therapy, she was having humapen ergo unknown body type but her grand children threw it to the ground so humapen cartridge holder got broken.On an unknown date in (b)(6) 2020, she bought a cartridges pack of insulin lispro that was different from any other pack she previously bought (pc (b)(4), lot d062140g).The insulin lispro cartridge color was white instead of maroon and the insulin lispro itself was not clear.Upon using that pack in specific, she went into a coma (diabetic coma), her blood glucose level increased and acetone levels increased in her body (units and values not provided), also she was not able to control herself.Information regarding any corrective treatment was not provided.Outcome of event wrong technique was unknown while she was fully recovered from the remaining events.Therapy with insulin lispro was ongoing.The operator of the humapen ergo unknown body type was patient and her training status was unknown.The general and suspect humapen ergo unknown body type duration of use was not provided.The action taken with humapen ergo unknown body type was unknown and it was not returned to the manufacturer.The initial reporting consumer related the events to insulin lispro therapy and did not relate the events to humapen ergo unknown body type.Edit 17dec2020: updated medwatch fields for expedited device reporting.No new information added.Update 23dec2020: entered the device specific safety summary (dsss).Updated the medwatch and european and (b)(6) (eu/(b)(6)) device fields for expedited device reporting.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO
• 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: 11124088
• MDR Text Key: 231956040
• Report Number: 1819470-2020-00179
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2020
• Initial Date FDA Received: 01/06/2021
• 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): Other
• Patient Age: 57 YR