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

Model Number UNKNOWN

Device Problems Failure to Deliver (2338); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.This device was associated with an increased blood sugar which was hospitalized on (b)(6)2021 and was hospitalized due to diabetes mellitus on an unreported date in (b)(6) 2021.

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 adverse events and product complaint (pc), concerned a male patient of unknown age and origin.Medical history and concomitant medications was not reported.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog 50/50 100 u/ml) from an cartridge, via a reusable device humapen (body type and color: unknown), for the treatment of diabetes mellitus, beginning on an unknown date.Dose, frequency, route of administration was not provided.On an unknown date, in (b)(6) 2021, after starting insulin lispro protamine suspension 50%/insulin lispro 50%, he was hospitalized due to diabetes, high blood glucose and high blood pressure.In (b)(6) 2021, after starting insulin lispro protamine suspension 50%/insulin lispro 50%, the injection button of the insulin injection pen was pushed down to the end without clicking sounds.He did not inject insulin lispro protamine suspension 50%/insulin lispro 50% due to this pen issue, blood glucose was high (values, units and reference ranges were not provided) ((b)(4); lot unknown).On (b)(6) 2021, he was hospitalized due to high blood glucose.On (b)(6) 2021, he was discharged from hospital.Outcome of event high blood glucose was not resolved.Further information regarding first hospitalization, corrective treatment, outcome of remaining events and therapy status of insulin lispro protamine suspension 50%/insulin lispro 50% was unknown.The user of the humapen device was patient and his training status was not provided.The general humapen device duration of use was approximately 2 years and it was started in 2019, suspect humapen device duration of use was not provided.The action taken with the suspect humapen device was not provided.The suspect humapen (unknown lot) unknown device type, associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if events of high blood glucose and missed dose were related and did not provide relatedness of remaining events with insulin lispro protamine suspension 50%/insulin lispro 50% treatment.The reporting consumer related the events of high blood glucose and missed dose and did not provide relatedness of remaining events with humapen device issue.Update 12-aug-2021: additional information was received from initial reporter on 11-aug-2021 in response to medical questionnaire.Added lab data for blood glucose and blood pressure, hospital discharge date for event of high blood glucose and two serious events of hypertension and diabetes mellitus inadequate control.Updated causality statement and narrative with new information.Update 31aug2021: additional information received on 27aug2021 from global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen (unknown lot) unknown device type, associated with product complaint (b)(4) which was not returned to the manufacturer.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 46285
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12408161
• MDR Text Key: 272558206
• Report Number: 1819470-2021-00104
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• 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