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

Model Number UNKNOWN

Device Problem Misfire (2532)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.Please refer to statement dated 19mar2020.No further follow up is planned.Evaluation summary.A male patient reported his humapen (unknown device type) "became hard" and was not injecting insulin.He experienced diabetic metabolic decompensation.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.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.Humapen device core instructions for use state to always carry a spare insulin pen in case your pen is lost or damaged.The patient reported that he has defective vision, stored the device in the refrigerator, and uses needles three times.Humapen device core instructions for use state the is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use it.Humapen device core instructions for use also state to use a new needle for each injection and to not store the device in a refrigerator.There is evidence of improper use and storage.The patient reused needles.Needle reuse may be relevant to the complaint and the event of diabetic metabolic decompensation.The patient stored the device in the refrigerator and used the device while visually impaired.It is unknown if these misuses are relevant to the complaint and the event of diabetic metabolic decompensation.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by two consumers who contacted the company to report a product complaint and adverse events, concerns a (b)(6) year old male patient of unknown ethnicity.Medical history of patient was not provided.Concomitant medications included insulin glulisine, insulin aspart and metformin for diabetes type 1.The patient received human insulin (rdna origin) nhp (humulin n) via vial and he also received human insulin (rdna origin) regular (humulin r) via a red reusable pen (unknown manufacturer), both at an unknown dose, frequency, route of administration, for diabetes type 1, beginning on unknown date.The second reporting consumer believed that the unknown red reusable pen was from the company.Since patient was (b)(6) years old (around 2009), the second reporting consumer did not know if after starting human insulin nph and regular and the unknown red reusable pen in the refrigerator, the patient started having defective vision due to diabetes.The patient had not recovered from this event.Since an unknown date, unknown time after starting human insulin nph and regular, the patient kept the human insulin nhp and regular and the unknown red reusable pen in the refrigerator, the patient reused each needle three times, after 3 uses the needle started hurting.The outcome of the events of injection site pain and the patient storaged the in use human insulin regular refill in the refrigerator were not reported.On unknown date, the red reusable pen (lot unknown / pc (b)(4)) stopped injecting, became hard, stopped working.The patient knew that this pen was not injecting because on unknown date, unknown time after starting human insulin nph and regular and the unknown red reusable pen, he felt unwell at work on the same day that the pen misfired, he had a diabetes crisis, his diabetes was very decompensated (the glycemia was high and then low) and the patient was hospitalized for two or three days.The patient had recovered from this event.The patient thought that the decompensated diabetes was not related to the pen, but related to keeping it in the refrigerator.Information regarding exams and corrective treatment was not provided.Human insulin nph and regular were continued but it was unknown if any action was taken with them.The patient was the operator of the device but it was unknown if he was trained.The duration of use of this device model and the duration of use of this suspect device was unknown.Since the device was discarded, it was not returned to the manufacturer.The second reporting consumer did not consider the decompensated diabetes related to the unknown red reusable pen.Neither reporting consumers provided any other opinion of relatedness.Update 19mar2020: additional information received on 19mar2020 from the global product complaint database.Entered the device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for the suspect device associated with (b)(4).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,
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, in
• MDR Report Key: 9948731
• MDR Text Key: 196780114
• Report Number: 1819470-2020-00032
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/10/2020
• 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): Hospitalization
• Patient Age: 22 YR