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

Model Number MS9557

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Missed Dose (2561)

Event Date 10/02/2019

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 follow up report will be submitted when the final evaluation is completed.

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 an approximately a (b)(6) female patient of unknown ethnicity.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, cartridge), via a reusable pen device (humapen ergo ii), at morning 20 units and night 20 units; twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning sometime in (b)(6) 2019.Sometime in (b)(6) 2019 (conflicting, also reported as (b)(6) 2019), while on human insulin 30/70 treatment, her humapen ergo ii screw was stuck and the dose adjustment did not rotate (pc number: (b)(4) and lot number: 1806d03) due to which she had missed several doses.In (b)(6) 2019, her blood pressure reached 170/100 mmhg (reference ranges were not provided) and she was diagnosed with hypertension since she missed doses (as reported).Since (b)(6) 2019, she also started to suffer from high blood glucose and that reached 600 mg/dl.Since an unknown date, she had been taking her doses with syringe.On (b)(6) 2019, her blood glucose decreased to 400 mg/dl.She was recovering from the event of blood glucose increased.Information regarding additional corrective treatment was not provided.She was not recovered from the remaining events.Human insulin isophane suspension 70%/human insulin 30 treatment was continued.The operator of the humapen ergo ii device and his/her training status was not provided.The humapen ergo ii device general model duration was not provided and the suspect humapen ergo ii device model durations of use was approximately five months (started sometime in (b)(6).The humapen ergo ii device was discontinued and its return status was expected.The reporting consumer did not relate the events of blood glucose increased and missed dose while related hypertension with human insulin isophane suspension 70%/human insulin 30% treatment and related the events with the humapen ergo ii device.Edit: 09-dec-2019: updated medwatch and european and (b)(6) (eu/(b)(6) 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 statement dated 27dec2019 in the b.5.Field.No further follow up is planned.Evaluation summary.A female patient reported that the screw on her humapen ergo ii device "was stuck and the dose adjustment did not rotate." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1806d03, manufactured june 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to the device not working.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.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned an approximately a 55-years-old female patient of unknown ethnicity.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, cartridge), via a reusable pen device (humapen ergo ii), at morning 20 units and night 20 units; twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning sometime in (b)(6) 2019.Sometime in (b)(6) 2019 (conflicting, also reported as (b)(6) 2019), while on human insulin 30/70 treatment, her humapen ergo ii screw was stuck and the dose adjustment did not rotate (pc number: (b)(4) and lot number: 1806d03) due to which she had missed several doses.In (b)(6) 2019, her blood pressure reached 170/100 mmhg (reference ranges were not provided) and she was diagnosed with hypertension since she missed doses (as reported).Since (b)(6) 2019, she also started to suffer from high blood glucose and that reached 600 mg/dl.Since an unknown date, she had been taking her doses with syringe.On (b)(6) 2019, her blood glucose decreased to 400 mg/dl.She was recovering from the event of blood glucose increased.Information regarding additional corrective treatment was not provided.She was not recovered from the remaining events.Human insulin isophane suspension 70%/human insulin 30 treatment was continued.The operator of the humapen ergo ii device and his/her training status was not provided.The humapen ergo ii device general model duration was not provided and the suspect humapen ergo ii device model durations of use was approximately five months (started sometime in may-2019).The humapen ergo ii device was discontinued and was not returned to the manufacturer.The reporting consumer did not relate the events of blood glucose increased and missed dose while related hypertension with human insulin isophane suspension 70%/human insulin 30% treatment and related the events with the humapen ergo ii device.Edit 09dec2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 27dec2019: additional information received on 26dec2019 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields.Added the date of manufacture for the suspect device associated with pc (b)(4).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: 9459598
• MDR Text Key: 185301688
• Report Number: 1819470-2019-00216
• 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,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: 1806D03
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR