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

Model Number MS9557

Device Problems Failure to Deliver (2338); Physical Resistance/Sticking (4012)

Patient Problems Headache (1880); Dizziness (2194)

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 complaint: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6)-years-old male patient of (b)(6) nationality.Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug reaction were none.Concomitant medication were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable pen (humapen ergo ii, blue), twice daily (24 units in morning and 14units at night), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date (more than ten years ago at the time of initial report).On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, there was a situation that the injection button could not be pressed on the humapen ergo ii ((b)(4)/ lot number 1510d01) and the needle was changed when one insulin cartridge was changed (improper use).On an unknown date, his fasting blood glucose was high (blood glucose level 19, no units and reference ranges were provided).He also experienced headache and dizziness.On (b)(6) 2019, he was hospitalized due to the events.On (b)(6) 2019, he was discharged.As of (b)(6) 2019, the situation of headache, dizziness and high fasting blood glucose was recovering.Information regarding corrective treatment and laboratory test done during hospitalisation were not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The operator of the humapen ergo ii and his/her training status was not provided.The model humapen ergo ii duration of use and the suspect humapen ergo ii duration of use were not provided.The use of the suspect humapen ergo ii was ongoing and its return was expected.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% therapy and did not provide a relatedness assessment for the events to humapen ergo ii.Update 01-nov-2019: pc number was received from the affiliate on 29-oct-2019.Pc was previously processed.Edit 06nov2019: updated medwatch 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(s) dated 03dec2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported the injection button of his humapen ergo ii device could not be pushed down.The patient experienced increased blood glucose.The investigation of the returned device (batch 1510d01, manufactured october 2015) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The soft touch was partially detached from the device.This damage is consistent with the exposure to an unknown chemical while in the field.The user manual describes the proper care and storage of the device and states "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen." the patient reported changing the needle when the cartridge was changed.The user manual states to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This may be relevant to the complaint of increased blood glucose.The soft touch was damaged due to exposure to an unknown chemical while in the field (not related to the manufacturing process).Since the soft touch does not affect functionality of the device, this is likely not relevant to the increased blood glucose.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a 73-years-old male patient of han nationality.Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug reaction were none.Concomitant medication were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable pen (humapen ergo ii, blue), twice daily (24units in morning and 14units at night), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date (more than ten years ago at the time of initial report).On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, there was a situation that the injection button could not be pressed on the humapen ergo ii ((b)(4)/ lot number 1510d01) and the needle was changed when one insulin cartridge was changed (improper use).On an unknown date, his fasting blood glucose was high (blood glucose level 19, no units and reference ranges were provided).He also experienced headache and dizziness.On (b)(6) 2019, he was hospitalized due to the events.On (b)(6) 2019, he was discharged.As of (b)(6) 2019, the situation of headache, dizziness and high fasting blood glucose was recovering.Information regarding corrective treatment and laboratory test done during hospitalisation were not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The operator of the humapen ergo ii and his/her training status was not provided.The model humapen ergo ii duration of use and the suspect humapen ergo ii duration of use were not provided.The suspect device, which was manufactured in oct2015, was returned to the manufacturer on 28oct2019.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% therapy and did not provide a relatedness assessment for the events to humapen ergo ii.Update 01-nov-2019: pc number was received from the affiliate on 29-oct-2019.Pc was previously processed.Edit 06nov2019: updated medwatch fields for expedited device reporting.No new information added.Update 03dec2019: additional information received on 03dec2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device for (b)(4) associated with lot 1510d01 of a 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: 9366762
• MDR Text Key: 185090333
• Report Number: 1819470-2019-00201
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1510D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 67