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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Mechanical Problem (1384); 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.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2020-00101 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 a consumer who contacted the company to report an adverse event and product complaints (pcs), concerned a (b)(6) years-old (at the time of initial report) male patient of an unknown origin.Medical history included numbness of hand and foot.Concomitant medication included insulin human for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70) from a cartridge, via a reusable pen device (humapen luxura burgundy) using approximately since 2015 (from four to five years as of 31-jul-2020, at an unknown dose, daily, subcutaneously, for the treatment of diabetes mellitus, beginning approximately sometime in 2000 (reported as 10-20 years ago as of 31-jul-2020.Sometime in (b)(6) 2020 (reported as three to four months ago as of 31-jul-2020, he discontinued humapen luxura burgundy device and started using humapen ergo ii.On an unknown date, while on human insulin 70/30 treatment, he experienced high blood glucose (blood glucose value:10-20) (units and normal reference range not provided) due to which he was hospitalized on (b)(6) 2020 and stopped taking human insulin 70/30 treatment according to prescription and switched to human insulin (rdna origin) (humulin, unspecified type) from a cartridge, via reusable pen device (humapen ergo ii) device.On unknown dates since sometime in (b)(6) 2020, both devices injection buttons could not be pressed down and the humapen luxura burgundy and humapen ergo ii devices were left with 30 iu, 40 iu and the insulin inside the insulin injection pen was always unable to be finished by injection (possible underdose) (pc number: (b)(4) and lot number: unknown) and (pc number: (b)(4) and lot number: 1612d04).As of 31-jul-2020, he was still in the hospital.Information regarding additional corrective treatment and outcome for events was not provided.Human insulin 70/30 treatment was discontinued and it was unknown if restarted and human insulin treatment was continued.The operator of the humapen luxura burgundy and humapen ergo ii devices and his/her training status was not provided.The humapen luxura burgundy general model duration of use and the suspect humapen luxura burgundy was approximately five years.The humapen ergo ii device general model duration of use and the suspect humapen ergo ii was approximately four months.The humapen luxura burgundy device was discontinued, the humapen ergo ii device was continued and were not available for evaluation at the time of report and their return status was not provided.The reporting consumer did not relate the event of blood glucose increased while did not provide relatedness for the remaining event with human insulin 70/30 treatment.The reporting consumer did not provide any relatedness for the event of blood glucose increased while related the remaining event with humapen luxura burgundy and humapen ergo ii devices.Edit 06-aug-2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 10-aug-2020: additional information received on 10-aug-2020 from global product complaint database.Changed the lot number from unknown to 1612d04 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 13-aug-2020: information was received from the affiliate on 10-aug-2020 regarding the product complaint numbers of (b)(4) that were already processed in the case.No medically significant information was received and no changes were made to the case.
 
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 an adverse event and product complaints (pcs), concerned a 54-years-old (at the time of initial report) male patient of an unknown origin.Medical history included numbness of hand and foot.Concomitant medication included insulin human for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70) from a cartridge, via a reusable pen device humapen luxura (burgundy) using approximately since 2015 (from four to five years as of (b)(6) 2020), at an unknown dose, daily, subcutaneously, for the treatment of diabetes mellitus, beginning approximately sometime in 2000 (reported as 10-20 years ago as of (b)(6) 2020).Sometime in (b)(6) 2020 (reported as three to four months ago as of (b)(6) 2020), he discontinued humapen luxura (burgundy) device and started using humapen ergo ii.On an unknown date, while on human insulin 70/30 treatment, he experienced high blood glucose (blood glucose value:10-20) (units and normal reference range not provided) due to which he was hospitalized on (b)(6) 2020 and stopped taking human insulin 70/30 treatment according to prescription and switched to human insulin (rdna origin) (humulin, unspecified type) from a cartridge, via reusable pen device (humapen ergo ii) device.On unknown dates since sometime in (b)(6) 2020, both devices injection buttons could not be pressed down and the humapen luxura (burgundy) and humapen ergo ii devices were left with 30 iu, 40 iu and the insulin inside the insulin injection pen was always unable to be finished by injection (possible underdose) (pc number: (b)(4) and lot number: unknown) and (pc number: (b)(4) and lot number: 1612d04).As of (b)(6) 2020, he was still in the hospital.Information regarding additional corrective treatment and outcome for events was not provided.Human insulin 70/30 treatment was discontinued and it was unknown if restarted and human insulin treatment was continued.The operator of the humapen luxura burgundy and humapen ergo ii devices and his/her training status was not provided.The humapen luxura burgundy general model duration of use and the suspect humapen luxura burgundy was approximately five years.The humapen ergo ii device general model duration of use and the suspect humapen ergo ii was approximately four months.The humapen luxura (burgundy) device was discontinued, but the humapen ergo ii device was continued.The humapen luxura (burgundy) device associated with (b)(4) (unknown lot) was not returned to the manufacturer (reportedly after troubling shooting device worked normally).The humapen ergo ii associated with (b)(4) (lot 1612d04) was returned to the manufacturer on 10aug2020.The reporting consumer did not relate the event of blood glucose increased while did not provide relatedness for the remaining event with human insulin 70/30 treatment.The reporting consumer did not provide any relatedness for the event of blood glucose increased while related the remaining event with humapen luxura burgundy and humapen ergo ii devices.Edit 06-aug-2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 10-aug-2020: additional information received on 10-aug-2020 from global product complaint database.Changed the lot number from unknown to 1612d04 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 13-aug-2020: information was received from the affiliate on 10-aug-2020 regarding the product complaint numbers of (b)(4) that were already processed in the case.No medically significant information was received and no changes were made to the case.Update 14sep2020: additional information received on 11sep2020 and 11sep2020 from the global product complaint database processed together.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the humapen ergo ii device (lot 1612d04) associated with product complaint (b)(4) which was returned to the manufacturer, and the humapen luxura (burgundy) associated with product complaint (b)(4) (unknown lot) that was not returned to the manufacturer.Updated device malfunction fields from unknown to no for both devices.Updated device return status to returned to manufacturer and added date of manufacturer and date returned to manufacturer for humapen ergo ii.Corresponding fields and narrative updated accordingly.Edit 23sep2020: updated medwatch fields for expedited device reporting and added contact log according.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 14sep2020 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2020-00101 since there is more than one device implicated.This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary: a male patient reported that that the injection button of his humapen ergo ii device could not be pressed down and was left with 30 iu or 40 iu in the pen, unable to finish by injection.He experienced increased blood glucose.The investigation of the returned device (batch 1612d04, manufactured december 2016) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.
 
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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 Key10410638
MDR Text Key210378902
Report Number1819470-2020-00102
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1612D04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Date Manufacturer Received09/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age54 YR
Patient Weight69
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