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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); Use of Device Problem (1670); 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
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by consumer via patient support program (psp), concerned a male patient of unknown age and origin. Medical history, previous drug adverse reaction, family drug reaction were not provided. Concomitant medication was none. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable device (humapen ergo ii), 25units twice daily (morning and evening), subcutaneously, for the treatment of diabetes mellitus from an unknown date. On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, he had hyperglycaemia (value of high blood glucose and reference ranges were provided) which required hospitalisation. He was discharged (the time for hospitalization and the time for discharging was unknown). Reportedly in (b)(6) 2020, his humapen ergo ii was fallen off and was not as smooth as before (b)(4)/ lot number 1502d02). It was especially tight when pushing insulin out and was very not good to use (the injection button was difficult to be pushed down). He changed the needle once in every one or two days (improper use of device). Information regarding corrective treatment and outcome for the event was not provided. Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing. The patient was the operator of the humapen ergo ii and his training status was not provided. The humapen ergo ii model duration of use was not provided. The suspect humapen ergo ii duration of use was three years as it was started in 2017. The use of the suspect humapen ergo ii was ongoing and its return status was not provided. The reporting consumer did not provide a relatedness assessment between the event and human insulin isophane suspension 70%/human insulin 30% therapy or the humapen ergo ii. Edit 24aug2020: updated medwatch and (b)(6) fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis, in
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe, az
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key10459806
MDR Text Key204694323
Report Number1819470-2020-00112
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 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1502D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/27/2020 Patient Sequence Number: 1
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