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

Model Number MS9557

Device Problems Crack (1135); Activation, Positioning or Separation Problem (2906)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.

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 adverse events, concerned a (b)(6)(at the time of initial report) asian (han) male patient.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25, 100 u/ml) from a cartridge via a reusable humapen ergo ii (tone blue plastic) (humapen ergo ii was started to use in feb-2015), three times a day, (morning: 14 u, 13 u noon, 13 u night) subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.After using insulin lispro mix 25, on (b)(6) 2019 he was hospitalized to regulate blood pressure (blood pressure was 160/110), blood lipid and blood sugar (fasting blood glucose was 11-12, 16-17).On an unknown date, his systolic blood pressure was 140.He was recovering from increased blood pressure and increased blood glucose.On (b)(6) 2019, he was discharged from the hospital.On an unknown date, he had issues with humapen ergo ii as it had a gap when pushed down to the end and the injection button had a crack lately (product complaint # (b)(4), lot# 1210d01).Information regarding corrective treatment and outcome of the remaining event was not provided.Status of insulin lispro mix 25 therapy was ongoing.The operator of the reusable humapen ergo ii device and his/her training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable humapen ergo ii device duration of use was approximately four years as started in (b)(6) 2015.The action taken with status of suspect reusable humapen ergo ii device was unknown.The status of suspect reusable humapen ergo ii device was ongoing and the return of suspect reusable humapen ergo ii device was not provided.The initial reporting consumer did not know if the events were related to insulin lispro mix 25 drug, and did not provide relatedness assessment between the events and humapen ergo ii device.Update (b)(6) 2019: correction received from the affiliate about the information received on (b)(6) 2019.Affiliate made a non-med sig correction in the narrative and provided the same information as in the gps single record report.No new adverse event or product information was received.Edit (b)(6) 2019: upon review of the information received on 21-aug-2019, the approximate device age was added to the device tab and in fourth paragraph of narrative.No other changes were made to the case.Update (b)(6) 2019: additional information was received from initial reporter in response to medical questionnaire on (b)(6) 2019.Added lab data for blood glucose and blood pressure.Updated description as reported, coding and outcome for the events of blood glucose and blood pressure and narrative with new information.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a 47-years-old (at the time of initial report) asian (han) male patient.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix 25, 100 u/ml) from a cartridge via a reusable humapen ergo ii (tone blue plastic) pen (humapen ergo ii was started to use in (b)(6) 2015), three times a day, (morning: 14 u, 13 u noon, 13 u night) subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.After using insulin lispro mix 25, on (b)(6) 2019 he was hospitalized to regulate blood pressure (blood pressure was 160/110), blood lipid and blood sugar (fasting blood glucose was 11-12, 16-17).On an unknown date, his systolic blood pressure was 140.He was recovering from increased blood pressure and increased blood glucose.On (b)(6) 2019, he was discharged from the hospital.On an unknown date, he had issues with humapen ergo ii as it had a gap when pushed down to the end and the injection button had a crack lately (product complaint (b)(4), lot 1210d01).Information regarding corrective treatment and outcome of the remaining event was not provided.Status of insulin lispro mix 25 therapy was ongoing.The operator of the reusable humapen ergo ii device and his/her training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable humapen ergo ii device duration of use was approximately four years as it was started in (b)(6) 2015.The action taken with suspect reusable humapen ergo ii device was unknown.The reusable humapen ergo ii device associated with product complaint (b)(4)was not returned to the manufacturer.The initial reporting consumer did not know if the events were related to insulin lispro mix 25 drug, and did not provide relatedness assessment between the events and humapen ergo ii device.Update 27-aug-2019: correction received from the affiliate about the information received on 21-aug-2019.Affiliate made a non-med sig correction in the narrative and provided the same information as in the gps single record report.No new adverse event or product information was received.Edit 06-sep-2019: upon review of the information received on 21-aug-2019, the approximate device age was added to the device tab and in fourth paragraph of narrative.No other changes were made to the case.Update 10-sep-2019: additional information was received from initial reporter in response to medical questionnaire on 04-sep-2019.Added lab data for blood glucose and blood pressure.Updated description as reported, coding and outcome for the events of blood glucose and blood pressure and narrative with new information.Update 20sep2019: additional information received on 18sep2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen ergo ii device associated with product compliant (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Update 23-sep-2019: information received on 17-sep-2019.Follow-up attempt was made but initial reporter could not be contacted.No changes were made to the case.

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 20sep2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device "had a gap when pushed down to the end and the injection button had a crack lately." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (1210d01, manufactured october 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to injection button, lead screw difficult to advance or retract, or dose accuracy issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported using the device since (b)(6) 2015.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.It is unknown if this misuse is relevant to the event of increased blood glucose.

• 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: 9078545
• MDR Text Key: 163122391
• Report Number: 1819470-2019-00162
• 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: 10/03/2019

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: Other
• Device Model Number: MS9557
• Device Lot Number: 1210D01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 87