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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 Component Missing (2306); Device Fell (4014)
Patient Problems Infarction, Cerebral (1771); Complaint, Ill-Defined (2331)
Event Date 05/31/2016
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.
 
Event Description
(b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of an unknown origin.Medical history was not provided where as family history included mother had diabetes.Concomitant medications included metformin hydrochloride for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via a reusable humapen ergo ii device with 25-26 unit in the morning and 20 units at night two times a day via unspecified route for the treatment of diabetes mellitus, beginning sometime in 2005 in hospital on physician advice.On an unspecified date in 2011 while taking human insulin isophane suspension 70%/human insulin 30% treatment he experienced lacunar cerebral infarction.The event of lacunar cerebral infarction was considered as serious due to medically significant reasons.Approximately in (b)(6) 2013 or (b)(6) 2013 he was hospitalized and underwent cardiac stent surgery (reason was not provided).On (b)(6) 2016 he felt instability in his blood sugar control (values, units and reference range were not provided) and due to which he was hospitalized for 12 days.Approximately in (b)(6) 2016, on physician advice he discontinued human insulin isophane suspension 70%/human insulin 30% therapy and switched to insulin lispro protamine suspension 75%/insulin lispro 25% therapy.In addition, on an unspecified date, the humapen ergo ii fell down and one piece of the humapen ergo ii was missed ((b)(4)/ lot: 0803d04).Information regarding further hospitalization details, corrective treatment received and outcome of the events was not provided.It was unknown if he would re-start human insulin isophane suspension 70%/human insulin 30% treatment or not.The operator of the humapen ergo ii and his/her training status was not provided.The general model humapen ergo ii duration of use was unknown and the suspect humapen ergo ii duration of use was approximately six years as it was started approximately in 2010.At the time of the glucose event it had been used for about six years.The suspect device was returned on 19aug2019.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% treatment and did not provide a relatedness opinion between events and humapen ergo ii.Update 14-aug- 2019: initial information and follow-up information both received on (b)(6) 2019 were processed at the same time.Update 15-aug-2019: additional information received on 13-aug-2019 from the global complaint group.The suspect device was returned on 13-aug-2019; therefore the suspect device was updated from humapen ergo unknown type, to humapen ergo ii.Added lot number of the suspect device humapen ergo ii.The eu/ca fields and narrative were updated accordingly.Update 19aug2019: additional information received on 13aug2019 from global product complaint database.Reiterated the suspect device to be a humapen ergo ii device.Reiterated the lot number of 0803d04 for product complaint (b)(4) relating to the humapen ergo ii device.Updated the return status to returned to the manufacturer on 13aug2019.Corresponding fields and narrative updated accordingly.Edit 27-aug-2019: upon review of previous information, suspect device paragraph regarding model duration of uses was updated.No other change was made to the case.
 
Event Description
Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 60-year-old male patient of an unknown origin.Medical history was not provided whereas family history included mother had diabetes.Concomitant medications included metformin hydrochloride for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via a reusable humapen ergo ii device with 25-26 unit in the morning and 20 units at night two times a day via unspecified route for the treatment of diabetes mellitus, beginning sometime in 2005 in hospital on physician advice.On an unspecified date in 2011 while taking human insulin isophane suspension 70%/human insulin 30% treatment he experienced lacunar cerebral infarction.The event of lacunar cerebral infarction was considered as serious due to medically significant reasons.Approximately in (b)(6) 2013 or (b)(6) 2013 he was hospitalized and underwent cardiac stent surgery (reason was not provided).In addition, on an unspecified date, the humapen ergo ii fell down and one piece of the humapen ergo ii was missed (pc: (b)(4)/ lot: 0803d04).On (b)(6) 2016 he felt instability in his blood sugar control (values, units and reference range were not provided) and due to which he was hospitalized for 12 days.In addition, on an unspecified date, the humapen ergo ii fell down and one piece of the humapen ergo ii was missed (pc: (b)(4)/ lot: 0803d04).Approximately in (b)(6) 2016, on physician advice he discontinued human insulin isophane suspension 70%/human insulin 30% therapy and switched to insulin lispro protamine suspension 75%/insulin lispro 25% therapy.Information regarding further hospitalization details, corrective treatment received and outcome of the events was not provided.It was unknown if he would re-start human insulin isophane suspension 70%/human insulin 30% treatment or not.The operator of the humapen ergo ii and his/her training status was not provided.The general model humapen ergo ii duration of use was unknown and the suspect humapen ergo ii duration of use was approximately nine years as it was started approximately in 2010.At the time of the glucose event it had been used for about six years.The suspect device, which was manufactured in mar2008, was returned on 13aug2019.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% treatment and did not provide a relatedness opinion between events and humapen ergo ii.Update 08-aug-2019: initial information and follow-up information both received on 05-aug-2019 were processed at the same time.Update 15-aug-2019: additional information received on 13-aug-2019 from the global complaint group.The suspect device was returned on 13-aug-2019; therefore the suspect device was updated from humapen ergo unknown type, to humapen ergo ii.Added lot number of the suspect device humapen ergo ii.The eu/ca fields and narrative were updated accordingly.Update 19aug2019: additional information received on 13aug2019 from global product complaint database.Reiterated the suspect device to be a humapen ergo ii device.Reiterated the lot number of 0803d04 for product complaint (b)(4) relating to the humapen ergo ii device.Updated the return status to returned to the manufacturer on 13aug2019.Corresponding fields and narrative updated accordingly.Edit 27-aug-2019: upon review of previous information, suspect device paragraph regarding model duration of uses was updated.No other change was made to the case.Update 24sep2019: additional information received on 24sep2019 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 reiterated device return status to returned to manufacturer.Added date of manufacturer for pc (b)(4) associated with lot 0803d04 of humapen ergo ii device.Updated device age from 6 years to 9 years and updated narrative return date to 13aug2019.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 24sep2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that on an unknown date, he dropped his humapen ergo ii device and one piece of the pen cap was missing.The patient experienced abnormal blood glucose in (b)(6) 2016.The investigation of the returned device (batch 0803d04, manufactured march 2008) found the device met functional requirements.No malfunction was identified.The investigation also found the pen housing was cracked in two places, but there was no damage to internal components.The patient used the device since 2010.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.This is not likely relevant to the event since the device met functional requirements.
 
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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 Key8960826
MDR Text Key156627902
Report Number1819470-2019-00151
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 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number0803D04
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/13/2019
Date Manufacturer Received09/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age60 YR
Patient Weight80
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