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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 11aug2020.No further follow-up planned.Evaluation summary: the reporter stated the patient was an old guy that got bad eyes.There was no product complaint for the device and the device was not returned for investigation.There was evidence of improper use of the device.The patient used the device while his eyes got bad.The humapen (unknown device) is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it.Failure to follow the instructions may result in the wrong insulin dose being delivered.

Event Description

Lilly case id: (b)(4).This spontaneous case reported by a consumer who contacted the company to report adverse events, concerned a male patient of unknown age and origin.Medical history included being type i diabetic, being in insulin treatment and insulin glargine (lantus) as historical drug; also it caused him to have blood sugars out of control as it did not work.Concomitant medications included insulin glargine (toujeo) for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) via prefilled pen (kwikpen).Patient also received insulin lispro (rdna origin) injection (humalog) from cartridge via reusable device; humapen (unknown device).For both, indication for use, dosage regimen and start date were not reported.On unknown date, he was and old guy that got bad eyes and he did not feel secure about using the kwikpen as it did not click and he could not read the numbers without his glasses.Since unknown date, his blood sugars were out of control; they can go down to 20 and then he can go as high as 1200 (no units and normal ranges provided).The events of blood glucose increased and decreased were considered to be serious due to their medical significance.Information regarding corrective treatment, outcome of the event and the status of insulin lispro via kwikpen and the insulin lispro via cartridge were not reported.The operator of the kwikpen and humapen (unknown device) was the patient and his training status was not reported.The general and the suspect kwikpen and humapen (unknown device) duration of use were not reported.The action taken and the status of the kwikpen and humapen (unknown device) were not reported.The devices were not returned to the manufacturer.The reporting consumer did not provide assessment for the events and insulin lispro and/or the kwikpen or humapen (unkwnon device).Update 30jul2020: information received on 28jul2020 was contained in two different source documents that were processed at the same time.Update 11aug2020: entered a device specific safety summary (dsss) for the humapen (unknown device).Updated medwatch and european and (b)(6) fields for expedited device reporting.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 Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 10396818
• MDR Text Key: 208974518
• Report Number: 1819470-2020-00097
• 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
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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: 07/28/2020
• 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