MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problems Break (1069); Device Slipped (1584); Failure to Deliver (2338)

Patient Problems Hypoglycemia (1912); Tachycardia (2095); Coma (2417); Sweating (2444); Shaking/Tremors (2515)

Event Date 05/25/2019

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a female patient reported that on approximately on (b)(6) 2019, she experienced hypoglycemia and coma.On an unknown date, the cartridge holder of her humapen ergo ii "was slipped," and it was broken on approximately (b)(6) 2019.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.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of an unknown origin.Medical history included high blood pressure and hyperpiesia.Concomitant medications included acarbose and unspecified baitangping used for the treatment of type 2 diabetes mellitus, captopril used for the treatment of high blood pressure and acarbose for the treatment of unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25), unknown formulation via a reusable humapen ergo ii (deep-blue and slight-blue) device at a dose of 6 units in the morning and 7 units at night (12 units two times in a day conflicting information regarding dose) subcutaneously for the treatment of type 2 diabetes beginning on (b)(6) 2019.On (b)(6) 2019, she was hospitalized for an unknown reason.Information regarding further hospitalization details not provided.On (b)(6) 2019, at noon she experienced hypoglycemia.On (b)(6) 2019 to (b)(6) 2019 she experienced further episodes of hypoglycemia.Approximately on (b)(6) 2019, she experienced hypoglycemia and coma two hours after dinner.The blood glucose level was 2.8 (unit not provided).She had rapid heartbeat, sweating, hand shaking and felt shaking all over when hypoglycemia occurred.The event of hypoglycemic coma was considered as serious due to its medical significance.On an unknown date, cartridge holder was slipped, and it was broken and approximately on (b)(6) 2019, she stopped treatment with insulin lispro protamine suspension 75%/insulin lispro 25% due to pen issue (lot number: unknown, product complaint number: (b)(4)).Information regarding corrective treatment and outcome of the events were not provided.It was unknown if she would resume treatment with insulin lispro protamine suspension 75%/insulin lispro 25% or not.The operator of humapen ergo ii pen (blue) and his/her training status was not provided.The operator of humapen ergo ii pen (blue) and his/her training status was not provided.The general model humapen ergo ii pen (blue) duration of use and suspect humapen ergo ii pen (blue) duration of use was approximately 6 months as it was started approximately in (b)(6) 2019.The humapen ergo ii pen (blue) was discontinued approximately on (b)(6) 2019 and its return was expected.The reporting consumers did not provide the relatedness of the events with insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The initial reporting consumer did not provide the relatedness of the events with humapen ergo ii (blue) pen and second reporting consumer related the event of missed dose with product complaint associated with humapen ergo ii (blue) pen and did not provide relatedness for remaining events.Update (b)(6) 2019: this case was considered to be non-valid as there was no identifiable product.Edit (b)(6) 2019: upon review, the case was updated from valid to non-valid, abbreviated narrative was replaced by non-valid case statement.No further changes made in the case.Update (b)(6) 2019: information was received from the affiliate on 03-apr-2019.No medically significant information was added to the case.No changes were made.Update (b)(6) 2019: information received on 22-may-2019 from the affiliate stating that patient had been called for several times, but did not pick up the phone.No changes were made to the case and case remains non-valid due to no identifiable suspect product.Update (b)(6) 2019: this case was initially determined to be non-valid non serious (no valid event identifiable).Additional information received the initial reporter via psp on 29-may-2019 contain valid information.This case was upgraded to serious due to addition of serious event of hypoglycemic coma.Added medical history, concomitant medication.Updated narrative with new information.Update (b)(6) 2019: additional information was received from initial reporter via a psp on 20-aug-2019.Upon follow up, the case was upgraded due to addition of reusable suspect device.Added acarbose as concomitant medication, stop date of insulin treatment, reusable suspect device of humapen ergo ii (blue) and device element in narrative.Updated date of birth of patient, formulation of insulin treatment (from humalog 50 to humalog 25), action taken with insulin treatment (from no change to unknown), de-challenge/re-challenge (from n/a to unknown), causality statement and narrative with new information.Update (b)(6) 2019: additional information was received from second reporter (relative of patient) via a psp on 28-aug-2019.Added trackwise number ((b)(6)) and associated product complaint was processed, information regarding product complaint and one non-serious event of missed dose.Updated narrative with new information.Edit (b)(6) 2019: on review update device paragraph with model duration and suspect duration and device age in tab.Edit (b)(6) 2019: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information 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 with device information and the european and (b)(6) device information for the suspect humapen ergo ii device associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9083637
• MDR Text Key: 163316296
• Report Number: 1819470-2019-00161
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2019
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 32