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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 Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
Investigation in progress. This is an initial report. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2021-00086 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)(6) year-old female patient of (b)(6) 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 (b)(6) 2021. On an unknown date, she experienced high blood glucose. On an unknown date in (b)(6) 2021, she was hospitalized due to high blood glucose (no unit, value or reference range was reported). In around (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 (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 17-jun-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 21-jun-2021: both the documents received on 15-jun-2021 were processed together. Edit 29jun2021: updated medwatch and european and (b)(6) fields for expedited device reporting. No new information added. Edit 14jul2021: 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 Key12166193
MDR Text Key268073856
Report Number1819470-2021-00085
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 Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1910D04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2019
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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