BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 517914 · Received March 25, 2004

    Report

    Report Number
    1823260-2004-00180
    Event Type
    Injury
    Date Received
    March 25, 2004
    Date of Event
    March 6, 2004
    Report Date
    March 14, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER PERFORMED A BLOOD GLUCOSE TEST AND STATES THEY RECEIVED A READING OF 517MG/DL. TOOK 6 UNITS OF INSULIN. THINKS MAYBE IT WAS REALLY A RESULT OF 51MG/DL. ONLY REMEMBERS THAT PARAMEDICS WERE CALLED. WAS GIVEN D50. NO OTHER TREATMENT WAS GIVEN. UNK IF CONTROLS WERE USED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS CORP. NA 546637

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| R