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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 Break (1069); Crack (1135); Fracture (1260)
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 spontaneous case, reported by a consumer, concerns a (b)(6) years old asian (nationality reported as (b)(6)) male patient. Medical history included cardiovascular disease. Concomitant medication included metformin for unknown indication. The patient received human insulin isophane suspension (nph) 70% and human insulin 30% (rdna origin) (humulin 70/30) via humapen ergo ii, 18 units, twice a day (18 units at morning and 18 units at evening), subcutaneously for diabetes mellitus, beginning at an unspecified date in 2008 or 2010. At an unknown date and unknown period since beginning insulin nph 70% and human insulin 30% treatment via humapen ergo ii, it was reported that the effect was not good, the patients blood glucose could not be controlled (lot number was not provided; product complaint (pc) number (b)(4)). Additionally, it was reported that, around 2012 or 2013, the humapen ergo ii was replaced because the screw thread of the cartridge holder (connecting the needle) was cracked (lot number was not provided; pc number (b)(4)). The insulin nph 70% and human insulin 30% treatment was changed to insulin npl 75% and insulin lispro 25% (rdna origin) (humalog mix25) via humapen ergo ii, 18 units, twice a day (18 units at morning and 18 units at evening), subcutaneously for diabetes mellitus, beginning in 2014 or 2015. It was reported that in (b)(6) 2021, the screw thread of the cartridge holder of the humapen ergo ii was cracked and there were small transparent plastic pieces falling off (lot number 1311d02; pc number (b)(4)). At an unknown date and unknown period since beginning with insulin npl 75% and insulin lispro 25% via humapen ergo ii, the patients blood glucose was not regulated, therefore on (b)(6) 2021 he was hospitalized for regulating the blood glucose. Then, the insulin npl 75% and insulin lispro 25% therapy was changed to insulin npl 50% and insulin lispro 50%. At the time of the report the patient was still hospitalized. The outcome of the event, corrective treatment and laboratorial exams were not provided. It was unknown who was the operator of the device and the training status was not provided. The device model was used since 2008 or 2010. The first suspect device (lot unknown) was used from 2008 or 2010 to around 2012 to 2013, and the second suspect device (lot 1311d02 ) was used from 2012 or 2013 and was being used until the time of the initial report. The return status of the first suspect device was not expected, since it was replaced. The return status of the second suspect device was not provided. The reporting consumer did not know if the events were related to insulin nph 70% and human insulin 30% or insulin npl 75% and insulin lispro 25% treatment. Edit 21jul2021: updated medwatch and european (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 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 Key12241870
MDR Text Key268075139
Report Number1819470-2021-00098
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 consumer,foreign
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1311D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2013
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: 07/28/2021 Patient Sequence Number: 1
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