BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 36690 · Received August 30, 1996

    Report

    Report Number
    1823260-1996-00084
    Event Type
    Injury
    Date Received
    August 30, 1996
    Report Date
    August 30, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STANDARD DISCLAIMER ON FILE.

    Description of Event or Problem · 1

    A PT (HISTORY REQUESTED BUT NOT PROVIDED, EXCEPT THAT PT WAS DEHYDRATED) WAS BROUGHT TO THE HOSP IN A COMA BECAUSE OF INSULIN DOSAGE BASED ON RESULTS FROM THE SUSPECT DEVICE GAVE 130 OR 135 VS. LAB RESULT OF 96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING SYSTEM CFR BOEHRINGER MANNHEIM CORP. 870 (METER) 400267 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization