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

Device Problem Mechanical Problem (1384)

Patient Problem Hyperglycemia (1905)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement (s) dated (b)(6) 2021 in the describe event or problem field.No further follow-up is planned.Evaluation summary a female patient reported that her humapen (unspecified device type) was hard to use (unspecified issue).The patient experienced an aggravation of her diabetes mellitus.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.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of an unknown origin.Medical history was not provided.Concomitant medications included insulin aspartate for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) from cartridge via a reusable pen, humapen unknown device, at an unknown dose and unknown frequency, via subcutaneous route for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date in (b)(6) 2021, while on insulin lispro treatment, she had the recurrence of diabetes mellitus ((b)(4) and batch number- unknown), and due to which she was hospitalized on an unknown date.Information regarding corrective treatment, outcome of event and status of insulin lispro was not provided.The operator of the humapen unknown device and his/her training status was not provided.The humapen unknown device model duration of use and suspect humapen unknown device duration of use were not reported.The action taken with the suspect humapen unknown device was not reported and its return status was not expected.The reporting consumer did not provide relatedness of event with both insulin lispro and humapen unknown device.Edit 22-nov-2021: upon review of the information dated 04-nov-2021, updated suspect device from humapen ergo ii to humapen unknown device.No other information added to the case.Update 24nov2021: additional information received on 23nov2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information for (b)(4) associated with unknown lot of humapen unknown device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN UNKNOWN
• 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: 12929937
• MDR Text Key: 283266892
• Report Number: 1819470-2021-00161
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female