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

Lot Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problems Dehydration (1807); Diarrhea (1811); Fall (1848); Bone Fracture(s) (1870); Head Injury (1879); Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the updated statements.Please refer to update statement(s) dated 13sep2019.No further follow-up is planned.Evaluation summary: a consumer reported on behalf of a female patient that her humapen (unspecified device type) was not releasing insulin.The patient's daughter subsequently reported the injection button "wouldn't offer resistance" and "would go down really fast." the daughter reported that when she pressed the injection button, nothing was coming out.The patient experienced hyperglycemia and ketoacidosis.The device was not returned for investigation (batch 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.The patient reportedly stored the device in the refrigerator.The core instructions for use states to not to store the device in a refrigerator.There is evidence of improper use and storage.The patient stored the device in the refrigerator.It is unknown if this is relevant to the events of hyperglycemia and ketoacidosis.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report a product complaint (pc), concerns a female patient of unknown age and origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injection (humalog) and insulin glargine (basaglar), via prefilled pen, unknown dose, frequency, route of administration or indication, beginning on an unknown date.On an unknown date, the patient started receiving both insulins via a reusable humapen (unknown device).Approximately in (b)(6) 2019, unknown time after commencing the treatment with insulin lispro and insulin glargine via humapen unknown device, the medication did not have the expected effect as the patient presented constant hyperglycemia, also described as blood glucose did not decrease, and she went to the emergency room several times.It was reported that it happened during two or three months.As corrective treatments, the patient received saline solution, insulin regular and human, but the patient did not recover from hyperglycemia.On an unknown date, a hospitalization was necessary due to the hyperglycemia.Approximately in (b)(6) 2019, the patient vomited a lot, fell and hit her head.Blood glucose was still measuring high (as reported).The patient went to the emergency room with mental confusion, dehydrated, experiencing diarrhea and vomiting, with ketoacidosis.The patient stayed hospitalized during two days due to these events and no diagnosis was made.As corrective treatment for the head injury, she received stitches.The patient was discharged on an unknown date.On an unspecified date, the patient fell and broke the femur.Due to these events, she was hospitalized once more, mending one hospitalization to the other.After performing a check of the device, it was detected that it was not releasing insulin (pc 4855034/lot unknown) and due to this patient did not received both medications.Moreover, it was reported that both in-use insulins and the device were stored in the refrigerator.Information regarding corrective treatments for the remaining events and outcomes were not reported.It was unknown if insulin glargine and insulin lispro treatment were continued.The patient operated the device.It was unknown if she was trained.The duration of use for this device model was unknown and for this reported device lot unknown was seven months.The suspect device was not returned to the manufacturer.The reporting consumer stated that in the beginning it was thought that the events were related to insulin lispro and insulin glargine or to their dosage, however due to the problem with the device, the reporter related drug dose omission and hyperglycemia to the device.No other opinion of relatedness was provided.Update (b)(6) 2019: no new information was received on 27aug2019.No medically significant information was added to the case.Update (b)(6) 2019: additional information received on 30aug2019 from the initial reporting consumer.Added vomited a lot, two episodes of fall, hit her head, mental confusion, dehydrated, diarrhea, vomiting, ketoacidosis and broke the femur as serious events; information regarding hospitalizations; corrective treatments for hyperglycemia.Updated start date of hyperglycemia; operator of the device.Narrative and corresponding fields were updated accordingly.Edit (b)(6) 2019: upon internal review, an edit was completed in order to add insulins were stored in the refrigerator as non-serious event and update improper use of the device.Update (b)(6) 2019: additional information received on 09sep2019 and 10sep2019 from the global product complaint database which were processed together.No new information was added.Update (b)(6) 2019: additional information received on 13sep2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for pc 4855034 associated with unknown lot of 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 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9099380
• MDR Text Key: 163939466
• Report Number: 1819470-2019-00166
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2019
• 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): Hospitalization