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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); Failure to Deliver (2338); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned. Usage concerns resolved, and device was reported to be working properly. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2021-00085 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 consumers who contacted the company to report adverse events, concerned a (b)(4) female patient of han nationality. Medical history included endometritis, poor lung and other unspecified diseases. Concomitant medications included metformin for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) from a cartridge, via a reusable device (humapen ergo ii), 12 units in the morning and 18 units at the evening, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2019. On an unknown date, her eyes were not good and it was getting severe. In around beginning of (b)(6) 2021, the injection button of the humapen ergo ii could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once (pc number: (b)(4), lot number: 1603d01). She started using another humapen ergo ii in around end of (b)(6) 2021. On an unknown date, she experienced high blood glucose. On an unknown date in may-2021, she was hospitalized due to high blood glucose (no unit, value or reference range was reported). In around beginning of (b)(6) 2021, the injection button of the second humapen ergo ii could not be pressed down, sometimes there was no clicking sound when it was pressed down to the end at once (pc number: (b)(4), lot number: 1910d04). Information regarding corrective treatments was unknown. She was not recovered from the event of eye were not good and outcome of the remaining event was unknown. Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued. The operators of the humapen ergo ii device and their training status were not provided. The general humapen ergo ii reusable device model duration of use was approximately one year and 10 months. The first suspect humapen ergo ii device duration of use was around five months and second suspect humapen ergo ii device duration of uses was less than one months as it was used from end of (b)(6) 2021 to around the beginning of (b)(6) 2021. Issue of first humapen ergo ii reusable device was resolved and its return was not expected. The second suspect humapen ergo ii device was returned to the manufacturer on (b)(6) 2021 and its investigation was in progress. The initial reporting consumers did not know if the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas did not provide relatedness assessment between the events humapen ergo ii devices. Update (b)(6) 2021: both the documents received on (b)(6) 2021 were processed together. Edit (b)(6) 2021: updated medwatch and (b)(6) and (b)(6) fields for expedited device reporting. No new information added. Edit (b)(6) 2021: updated medwatch fields for expedited 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 Key12166194
MDR Text Key267639312
Report Number1819470-2021-00086
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 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1603D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2016
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: 07/14/2021 Patient Sequence Number: 1
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