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

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.This is an initial report.A follow-up report will be submitted when then final evaluation is completed.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) male patient of (b)(6) origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) via a cartridge from reusable device humapen ergo 2, subcutaneously for the treatment of diabetes mellitus beginning approximately on an unknown date in 2007.Dose and frequency of human insulin isophane suspension 70%/human insulin 30% was not reported.On an unknown date, during using of human insulin isophane suspension 70%/human insulin 30%, his blood glucose was not controlled (values not provided), so on an unknown date in (b)(6) 2017, she was hospitalized and approximately on (b)(6) 2017, he was discharged from the hospital.As on (b)(6) 2017, his fasting blood glucose was 9-10 (unit and reference range not reported), the postprandial blood glucose was about 14 (unit and reference range not reported) ((b)(4) lot number: 0808d03).Information regarding corrective treatment was not reported.Outcome of the event was reported as recovering.Human insulin isophane suspension 70%/human insulin 30% therapy was continued.Follow up not possible as the reporting consumer refused to be followed up via phone and hcp contact details not provided.The operator of humapen ergo 2 and its training status was unknown.The general humapen ergo 2 duration of use was not known but started approximately in 2007 and the suspect humapen ergo 2 duration of use was not provided.If device was returned, evaluation would be performed to determine if a malfunction has occurred.The reporting consumer considered the event was related with human insulin isophane suspension 70%/human insulin 30% therapy and did not provide relatedness with device.Update 27-dec-2017: information received from local affiliate on 26-dec.2017 provided product complain number.No further information provided.Update 09jan2018: updated medwatch fields for expedited device reporting.No new information added.Edit: 10-jan-2018: upon review of information received on 18-dec-2017, updated eu/ca fields.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) male patient of asian origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) via a cartridge from a reusable device humapen ergo ii, subcutaneously for the treatment of diabetes mellitus beginning approximately on an unknown date in 2007.Dose and frequency of human insulin isophane suspension 70%/human insulin 30% was not reported.On an unknown date, during using of human insulin isophane suspension 70%/human insulin 30%, his blood glucose was not controlled (values not provided), so on an unknown date in (b)(6) or (b)(6) 2017, he was hospitalized and approximately on (b)(6) 2017, he was discharged from the hospital.As on (b)(6) 2017, his fasting blood glucose was 9-10 (unit and reference range not reported), the postprandial blood glucose was about 14 (unit and reference range not reported).At that same time also reported as recently, it was noted that the cartridge holder of his humapen ergo ii was cracked ((b)(4) lot number: 0808d03).Information regarding corrective treatment was not reported.Outcome of the event was reported as recovering.Human insulin isophane suspension 70%/human insulin 30% therapy was continued.Follow up not possible as the reporting consumer refused to be followed up via phone and hcp contact details not provided.The operator of humapen ergo ii and his training status was unknown.The general humapen ergo ii duration of use was not known but started approximately in 2007 and the suspect humapen ergo ii duration of use was not provided.The suspect device with pc 4217195, which was manufactured in aug 2008, was returned to the manufacturer on 25dec2017.Upon investigation, it was noted that the cartridge holder was broken (which was taped) and the needle thread was cracked which made the device not function properly.The reporting consumer considered the event was related with human insulin isophane suspension 70%/human insulin 30% therapy and did not provide relatedness with device.Update 27-dec-2017: information received from local affiliate on 26-dec.2017 provided product complain number.No further information provided.Update 09jan2018: updated medwatch fields for expedited device reporting.No new information added.Edit: 10-jan-2018: upon review of information received on 18-dec-2017, updated eu/(b)(6) fields.Update 01feb2018: additional information received on 31jan2018 and 01feb2018 from the global product complaint database; both were processed together.Entered device specific safety summary (dsss).Updated medwatch/european and (b)(6) (eu/(b)(6)) device information, improper use and storage from no to yes, malfunction from unknown to yes/not cirm 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 0808d03 of humapen ergo ii.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated (b)(6) 2018 in the describe event or problem field.No further follow-up is planned.Evaluation summary: a male patient reported that the cartridge holder of his humapen ergo ii was cracked recently.The device was returned with tape wrapped around the cartridge holder.The investigation of the device (batch 0808d03, manufactured august 2008) found the cartridge holder was broken at the device attachment end and cracked at the needle thread end.The damage to the cartridge holder rendered the device non-functional.Malfunction confirmed.However, testing of the device using a designated cartridge holder found the device met functional requirements, and met dose accuracy and glide (injection) force specifications.The core instructions for use states if any of the parts of your humapen ergo ii device appear broken or damaged, do not use.It further instructs the patient to not use the device if it appears broken or damaged and to contact lilly or their healthcare provider for a replacement pen.The patient reported having obtained the device more than 10 years ago; however, the device was manufactured in august 2008.Therefore, the patient likely used the device for just under 10 years, which is beyond its approved use life.The core instructions for use states the device was designed to be used for up to 3 years after first use.There is evidence of improper use.The damage to the cartridge holder, rendering the device non-functional, is consistent with damage while in the field.This may be relevant to the event of abnormal blood glucose.Additionally, the patient used the device beyond its approved use life.It is unknown if this is relevant to the event of abnormal 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: 7194059
• MDR Text Key: 97497102
• Report Number: 1819470-2017-00232
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0808D03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization