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

Model Number MS9557

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Date 02/23/2019

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A report will be submitted when the final evaluation has been completed.

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 an adverse event, concerned an (b)(6) asian female patient.Medical history included myocardial infarction and high blood pressure.Concomitant medications were not reported.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injection (humalog mix50) cartridges via reusable pen (humapen ergo ii) 06 units in the morning, 06 units in the afternoon and 06 at night three times a day; subcutaneously for the treatment of diabetes mellitus.Start date was not provided.Since an unknown date, she developed diabetic syndrome.Since an unspecified date, she had to be hospitalized every year due to high blood pressure and diabetic syndrome.On (b)(6) 2019, her blood glucose reached more than 20 (no units provided).On (b)(6) 2019, her blood glucose reached 30.8 (no units provided) due to a failure in her humapen ergo ii device.The event of blood glucose increased was considered to be serious due to medical significance.On the evening of (b)(6) 2019, she borrowed a humapen ergo ii from her neighbor to give her injection but after the injection her blood sugar returned to normal.As of (b)(6) 2019, she was recovered from the blood glucose increased event.Information regarding corrective treatments and outcome of the remaining events was not provided.Insulin lispro therapy was continued.The user of the device and his/ her training status was not provided.The device model duration of use and the suspect devices duration of use were not reported.The action taken and the return status of the suspect devices were not known.The reporting consumer did not know if the events were related to insulin lispro or the device.Edit 07mar2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 27mar2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a family member of a female patient reported that the injection button of her humapen ergo ii could not be pushed down on (b)(6) 2019, but after replacing the needle and cartridge, the injection button could be pushed down.The reported further stated that the injection button could be pushed down on (b)(6) 2019, but no insulin was delivered.The patient experienced increased blood glucose.The patient borrowed a humapen from a neighbor to inject insulin on the evening of (b)(6) 2019, and the patient's blood glucose returned to normal.The complaint device was not returned for investigation (batch 1102d02, manufactured february 2011).However, subsequently the pen was checked by a diabetes educator; the issue was solved, and the pen was working normally.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The core instruction for use states, "do not share your pen or needles as this may risk transmission of infectious agents" and "always carry a spare insulin pen in case your pen is lost or damaged." there is evidence of improper use.The patient used another individual's pen.This is not likely relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned an 81-years-old asian female patient.Medical history included myocardial infarction and high blood pressure.Concomitant medications were not reported.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injection (humalog mix50) cartridges via a reusable humapen ergo ii pen, 06 units in the morning, 06 units in the afternoon and 06 at night three times a day; subcutaneously for the treatment of diabetes mellitus.Start date was not provided.Since an unknown date, she developed diabetic syndrome.Since an unspecified date, she had to be hospitalized every year due to high blood pressure and diabetic syndrome.On (b)(6) 2019, her blood glucose reached more than 20 (no units provided).On (b)(6) 2019, her blood glucose reached 30.8 (no units provided) due to a failure in her humapen ergo ii device, further it was described as the injection button could not be pushed down even after replacing with a new needle ((b)(4)/lot 1102d02).The event of blood glucose increased was considered to be serious due to medical significance.On the evening of (b)(6) 2019, she borrowed a humapen ergo ii from her neighbor to give her injection but after the injection her blood sugar returned to normal.As of (b)(6) 2019, she was recovered from the blood glucose increased event.Information regarding corrective treatments and outcome of the remaining events was not provided.Insulin lispro therapy was continued.The user of the device and his/ her training status was not provided.The device model duration of use and the suspect devices duration of use were not reported.The suspect device, which was manufactured in feb2011, was reportedly working as the operational issue was solved by the diabetic educator so the device was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro or the device.Edit 07mar2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 08mar2019: upon internal review as determined causality was updated for dose omission.Update 27mar2019: additional information received on 26mar2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, improper use and storage from no to yes, malfunction from unknown to no, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1102d02 of humapen ergo ii device.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
• MDR Report Key: 8408803
• MDR Text Key: 138780273
• Report Number: 1819470-2019-00034
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

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: MS9557
• Device Lot Number: 1102D02
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 63