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

Model Number UNKNOWN

Device Problem Connection Problem (2900)

Patient Problem Hypoglycemia (1912)

Event Date 03/31/2021

Event Type  Injury  

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a female patient of an unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received insulin human (rdna origin) injections (humulin 100u/ml) via reusable pen humapen (unknown specific model) device, 24 units in morning, 22 units in evening, subcutaneously, for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, while on insulin human treatment, when the blood glucose was high (dose and units not provided), it was injected a little more, when the blood glucose was low, it was injected a little less ((b)(4), batch number unknown).She also had the situation of hypoglycemia, sometimes 1.8 (units not provided), sometimes 1.6, 1.1 when it was the lowest and due to hypoglycemia, she went to the hospital for the emergency four to five times and being hospitalized.Her family member rescued her for not less than 20 times in the home (no further information was provided.Later, because of the dizziness caused by hypoglycemia, on an unknown date in (b)(6) 2021, she fell then the leg was broken, the bone of thigh was fractured, it was not recovering up to then.Events fall and femur fracture were considered as serious by the company due to their medical significant reasons.Additionally, the situation that the brain was not so good.Information regarding further hospitalization details and corrective treatment was not provided.Outcome of event bone fracture was not resolved while outcome of remaining events was not provided.Status of insulin human was unknown.Follow up was not possible as reporter was not willing to be followed up via phone.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 humapen unknown device was discarded.The suspect humapen unknown specific model device (unknown lot) associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know relatedness of event with insulin human while did not provide relatedness of events with humapen unknown device.Edit 17-sep-2021: upon review of the information, pc number added in the narrative.Edit 17sep2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 01oct2021: additional information received on 28sep2021 from the 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 specific model device (unknown lot) associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

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 when using her humapen (unspecified device type) "the cartridge holder could not be screwed up to the pen body, insulin could not be ejected out." the patient experienced hypoglycemia.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.The reported complaint that insulin could not be ejected from the device could not have caused the serious incident of hypoglycemia.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 12583750
• MDR Text Key: 281101398
• Report Number: 1819470-2021-00127
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1