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

Model Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 24feb2020.No further follow-up is planned.Evaluation summary: a pharmacy technician reported on behalf of a female patient that the patient's humapen (unspecified device type) was "shooting through" and she was not sure if she was getting the correct dose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Subsequently, the patient reported that she had been using the device wrong, and the diabetes educator had got it working.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 evidence of improper use.The patient admitted using the device incorrectly.This may be relevant to the complaint.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a pharmacy technician who contacted the company to report an adverse event and a product complain (pc), concerns a female patient in her (b)(6) of an unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) cartridge via an unspecified reusable device (humapen unknown) beginning in (b)(6) 2017.Dosage regimen, route of administration and indication for use were not reported.On an unspecified date, the humapen was not working; reportedly, it just looked like it was shooting through (pc: (b)(4) / lot: unknown), therefore she was not sure if she was getting the correct dose.The reporter considered the event of incorrect dose administered as serious due to its medical significance.According to patient, they had been using the device wrong and the diabetes educator had got it working.She was not hospitalized.Information regarding corrective treatment was not provided.The outcome of the event was not recovered.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment was ongoing.The user of the humapen and her/his training status was not provided.The humapen model duration of use and the duration of use of the humapen considered as suspect were not provided.The suspect device was ongoing and was not returned to the manufacturer.The reporting hcp did not relate the event to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy but related the event to the humapen device.Edit 01-oct-2019: upon review of initial information from (b)(6) 2019 and catool reconciliation.The case was upgraded to serious; the event of incorrect dose administered was assessed as serious due to medical significance by the reporter.Pc was received, processed and added to the narrative.Narrative and fields were updated accordingly.Information of global complaint database from 09-sep-2019 considered as non medically significant was also reviewed.The lot number of the suspect humapen was unknown, so the suspect humapen device model was not updated.Edit 20-jan-2020: medically significant serious criteria was selected for the event of incorrect dose administered.No other change was made to the case.Update 17-feb-2020: additional information was received from initial reporter in response to medical questionnaire on (b)(6) 2020.Updated preliminary comments and updated improper use to yes.Updated narrative with new information.Update 20feb2020: additional information received on 14feb2020 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, and device return status to not returned to manufacturer for pc (b)(4) associated with an unknown lot of a humapen (unknown device).Corresponding fields and narrative updated accordingly.Update 24feb2020: additional information received on 24feb2020 from the global product complaint database.Entered updated device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information and malfunction from unknown to no for pc (b)(4) associated with an unknown lot of a humapen (unknown) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, in ; 4334585
• MDR Report Key: 9746645
• MDR Text Key: 192432866
• Report Number: 1819470-2020-00013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• 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): Other
• Patient Age: 70 YR