BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 568873 · Received January 26, 2005

    Report

    Report Number
    1823260-2005-00182
    Event Type
    Injury
    Date Received
    January 26, 2005
    Date of Event
    January 21, 2005
    Report Date
    January 22, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SUSPECT DEVICE RESULT WAS 590 MG/DL. THE USER DOSED INSULIN AND TWO HOURS LATER RETEST AT 244 MG/DL. USER DIDN'T FEEL WELL AND CALLED THE PARAMEDICS. THE EMTS ARRIVED AND CHECKED THEIR GLUCOSE AND OBTAINED READINGS OF 170, 150, AND 140 MG/DL. THE EMT'S HAD USER EAT AND THEN TOOK USER TO THE ER. CONTROLS WERE NOT USED. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 548117

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R