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

Model Number MS9557

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Failure to Deliver (2338); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned.Usage concerns resolved, and device was reported to be working properly.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2021-00085 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by consumers who contacted the company to report adverse events, concerned a (b)(4) female patient of han nationality.Medical history included endometritis, poor lung and other unspecified diseases.Concomitant medications included metformin for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) from a cartridge, via a reusable device (humapen ergo ii), 12 units in the morning and 18 units at the evening, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2019.On an unknown date, her eyes were not good and it was getting severe.In around beginning of (b)(6) 2021, the injection button of the humapen ergo ii could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once (pc number: (b)(4), lot number: 1603d01).She started using another humapen ergo ii in around end of (b)(6) 2021.On an unknown date, she experienced high blood glucose.On an unknown date in may-2021, she was hospitalized due to high blood glucose (no unit, value or reference range was reported).In around beginning of (b)(6) 2021, the injection button of the second humapen ergo ii could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once (pc number: (b)(4), lot number: 1910d04).Information regarding corrective treatments was unknown.She was not recovered from the event of eye were not good and outcome of the remaining event was unknown.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The operators of the humapen ergo ii device and their training status were not provided.The general humapen ergo ii reusable device model duration of use was approximately one year and 10 months.The first suspect humapen ergo ii device duration of use was around five months and second suspect humapen ergo ii device duration of uses was less than one months as it was used from end of (b)(6) 2021 to around the beginning of (b)(6) 2021.Issue of first humapen ergo ii reusable device was resolved and its return was not expected.The second suspect humapen ergo ii device was returned to the manufacturer on (b)(6) 2021 and its investigation was in progress.The initial reporting consumers did not know if the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas did not provide relatedness assessment between the events humapen ergo ii devices.Update (b)(6) 2021: both the documents received on (b)(6) 2021 were processed together.Edit (b)(6) 2021: updated medwatch and (b)(6) and (b)(6) fields for expedited device reporting.No new information added.Edit (b)(6) 2021: updated medwatch fields for expedited 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 29jul2021in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00085 since there is more than one device implicated.This is a downgrade report that no longer meets the criteria for expedited reporting.Evaluation summary a female patient reported that the injection button of her humapen ergo ii device "could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once." she experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1603d01, manufactured march 2016).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.With the guidance of a trained professional, troubleshooting was performed, including priming the device, and the issue was resolved.A batch threshold review did not identify any atypical findings with regard to 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 and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by consumers who contacted the company to report adverse events, concerned a 72-year-old female patient of han nationality.Medical history included endometritis, poor lung and other unspecified diseases.Concomitant medications included metformin for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) from a cartridge, via a reusable device (humapen ergo ii), 12 units in the morning and 18 units at the evening, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in aug-2019.On an unknown date, her eyes were not good and it was getting severe.In around beginning of may-2021, the injection button of the humapen ergo ii could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once (pc number: (b)(4), lot number: 1603d01).She started using another humapen ergo ii in around end of may-2021.On an unknown date, she experienced high blood glucose.On an unknown date in may-2021, she was hospitalized due to high blood glucose (no unit, value or reference range was reported).In around beginning of jun-2021, the injection button of the second humapen ergo ii could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once (pc number: (b)(4) lot number: 1910d04).Information regarding corrective treatments was unknown.She was not recovered from the event of eye were not good and outcome of the remaining event was unknown.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The operators of the humapen ergo ii device and their training status were not provided.The general humapen ergo ii reusable device model duration of use was approximately one year and 10 months.The first suspect humapen ergo ii device duration of use was around five months and second suspect humapen ergo ii device duration of uses was less than one months as it was used from end of may-2021 to around the beginning of jun-2021.The humapen ergo ii device (lot 1603d01) associated with (b)(4) was not returned to the manufacturer as the device problem resolved with troubleshooting.The second suspect humapen ergo ii device was returned to the manufacturer on 17-jun-2021 and its investigation was in progress.The initial reporting consumers did not know if the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas did not provide relatedness assessment between the events humapen ergo ii devices.Update 21-jun-2021: both the documents received on 15-jun-2021 were processed together.Edit 29jun2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 14jul2021: updated medwatch fields for expedited reporting.No new information added.Update 29jul2021: additional information received on 27jul2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, malfunction from unknown to no.Added date of manufacturer for the device for the humapen ergo ii device (lot 1603d01) associated with (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit 25aug2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

• 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: 12166194
• MDR Text Key: 267639312
• Report Number: 1819470-2021-00086
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1603D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 78