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

Model Number MS9557

Device Problems Use of Device Problem (1670); Failure to Deliver (2338); Defective Device (2588); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

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

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a female patient of unknown age and origin.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), from cartridge via a reusable device humapen ergo ii, at sliding scale for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen and route of administration were not provided.On an unknown date, she stopped taking insulin lispro protamine suspension 75%/insulin lispro 25% due to an unknown reason and started insulin lispro (rdna origin) injection (humalog), from cartridge via a reusable device humapen ergo ii, at sliding scale for the treatment of diabetes mellitus.Dosage regimen and route of administration were not provided.She adjusted the dose according to the blood glucose value level (would increase the dose if the blood glucose was high).On (b)(6) 2021, she was hospitalized due to high blood glucose and high blood pressure caused by diabetes complication.On (b)(6) 2021, the injection button of the humapen ergo ii was hard to be pressed down and it could not be pushed down.On an unknown date, when blood glucose was 30-40, she could not inject as humapen ergo ii got impaired (lot number: 1406d01, (b)(4)).Further information regarding hospitalization, corrective treatment, outcome of the events and status of insulin lispro treatment was not provided.It was unknown if she would resume insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The operator of humapen ergo ii and his/her training status was not provided.The general humapen ergo ii duration and suspect humapen ergo ii duration was not provided.The status of humapen ergo ii was discontinued on (b)(6) 2021 as it got impaired and information regarding its return was not provided.The initial reporting consumer did not know if the events were related to insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The initial reporting consumer related the events of high blood glucose and hypertension with diabetic complication.The initial reporting consumer related the event of missed dose with the product complaint associate with humapen ergo ii, did not provide relatedness of high glucose and did not associate remaining events with humapen ergo ii.Edit 07sep2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 09sep2021: additional information received on 09sep2021 from global product complaint database.Changed the lot number from unknown to 1406d01 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a female patient of unknown age and origin.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), from cartridge via a reusable device humapen ergo ii, at sliding scale for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen and route of administration were not provided.On an unknown date, she stopped taking insulin lispro protamine suspension 75%/insulin lispro 25% due to an unknown reason and started insulin lispro (rdna origin) injection (humalog), from cartridge via a reusable device humapen ergo ii, at sliding scale for the treatment of diabetes mellitus.Dosage regimen and route of administration were not provided.She adjusted the dose according to the blood glucose value level (would increase the dose if the blood glucose was high).On (b)(6) 2021, she was hospitalized due to high blood glucose and high blood pressure caused by diabetes complication.On (b)(6) 2021, the injection button of the humapen ergo ii was hard to be pressed down and it could not be pushed down.(lot number: 1406d01, pc number: (b)(4)).On an unknown date, when blood glucose was 30-40, she could not inject as humapen ergo ii got impaired.Further information regarding hospitalization, corrective treatment, outcome of the events and status of insulin lispro treatment was not provided.It was unknown if she would resume insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The operator of humapen ergo ii and his/her training status was not provided.The general humapen ergo ii duration and suspect humapen ergo ii duration was not provided.The status of humapen ergo ii was discontinued on (b)(6) 2021 as it got impaired and returned to the manufacturer for investigation on 09-sep-2021.The initial reporting consumer did not know if the events were related to insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The initial reporting consumer related the events of high blood glucose and hypertension with diabetic complication.The initial reporting consumer related the event of missed dose with the product complaint associate with humapen ergo ii, did not provide relatedness of high glucose and did not associate remaining events with humapen ergo ii.Edit 07sep2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 09sep2021: additional information received on 09sep2021 from global product complaint database.Changed the lot number from unknown to (b)(4) for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 19oct2021: additional information received on 18oct2021 from the global product complaint database.Entered device specific safety summaries (dsss) for pc (b)(4).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 pc (b)(4) associated with lot 1406d01 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.

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 19oct2021 in the b.5.Field.: no further follow-up is planned.Evaluation summary a female patient reported that on (b)(6) 2021, the injection button of her humapen ergo ii device "was (b)(6) 2021, she was hospitalized due to high blood glucose.The investigation of the returned device (batch 1406d01, manufactured june 2014) found the device met functional requirements.No malfunction was identified.There is no evidence of improper use or storage.This is a downgrade report that no longer meets the criteria for expedited reporting.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12470201
• MDR Text Key: 281754817
• Report Number: 1819470-2021-00119
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

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: 1406D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female