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

Model Number MS9557

Device Problem Unable to Obtain Readings (1516)

Patient Problems Stroke/CVA (1770); Erythema (1840); Hair Loss (1877); Loss of Vision (2139); Coma (2417); Blood Loss (2597)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 26jul2019.No further follow-up is planned.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerns a (b)(6)-year-old female patient of unknown ethnicity.Medical history of the patient included gallstone the size of a golf ball approximately in 2001; hyperthyroidism that became hypothyroidism in 2005 due to nuclear medicine (as reported); diabetes diagnosis about in 2009; use of metformin and unspecified insulin; weight gain; coma on (b)(6) 2012; use of regular human insulin injected with a syringe, which hurt; and memory impairment.Concomitant medication included metformin for unknown indication.The patient received insulin glargine (rdna origin) (basaglar) via disposable device, 22 units, daily and human insulin nph (humulin n) unknown formulation, both at unknown route of administration, for treatment of diabetes, beginning approximately in (b)(6) 2018.Also approximately in (b)(6) 2018, the patient started receiving regular human insulin (rdna origin) (humulin r) cartridge, via humapen ergo ii, 10 units in the morning, 8 units at lunch time and 10 units in the night (dinner time), unknown route of administration, for treatment of diabetes.On unknown date, unknown time to onset, the patient experienced a little red mark at the injection site and sometimes a little drop of blood came out of the injection site.Additionally, it was stated that the patient stored in use insulins inside the refrigerator.On (b)(6) 2018, approximately four months after starting treatment with insulin glargine, human insulin nph and human insulin regular, patient experienced a cerebrovascular accident (cva) and became blind due to the cva, which were considered serious by the company due to medically significant reasons.The patient also experienced hair loss due to the cva.In (b)(6) 2019, about seven months after starting human insulin regular via humapen ergo ii, insulin glargine and human insulin nph, the patient went to the dermatologist to perform an unspecified procedure and her blood glucose was so high that the device could not measure it.Conflicting information was also provided by reporter as cva and blood glucose high happened before insulin glargine, human insulin regular and human insulin nph.In (b)(6) 2019, the patient did a blood glucose test at home, and it was high.She went to the emergency room in an ambulance and had a diabetic coma.The events of blood glucose increased and diabetic coma were considered serious by the company due to medically significant reasons.In (b)(6) 2019, the patient returned to her prescribing physician and her dosage regimen was changed to 24 units of insulin glargine in the morning, and regular human insulin was changed to 8 units in the morning, 6 units at lunch time and 8 units at night (dinner time).Information regarding corrective treatment was not provided.The patient stopped storing in use insulins inside the refrigerator on unknown date.Outcome of the remaining events was unknown.Status of insulin glargine and human insulin regular and nph was not provided.It was unknown who operated the devices and their training status.Patient had used the device models and reported devices for unknown period of time.Return status of devices and action taken were unknown.The reporting consumer did not provide any opinion of relatedness.This case is cross-referenced to the cases (b)(4) (same patient).Update 10jul2019: additional information received on 04jul2019 from initial consumer reporter.Added serious events of increased blood glucose from (b)(6) 2019, diabetic coma and blindness and non-serious event of hair loss.Narrative and corresponding fields were updated accordingly.Edit 18jul2019: updated medwatch fields for expedited device reporting.No new information added.Update 26jul2019: entered a device specific safety summary (dsss) for the humapen ergo ii device.Updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.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: 8856611
• MDR Text Key: 153835772
• Report Number: 1819470-2019-00130
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2019
• 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: 66 YR