BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 383149 · Received March 14, 2002

    Report

    Report Number
    1823260-2002-00085
    Event Type
    Death
    Date Received
    March 14, 2002
    Date of Event
    February 14, 2002
    Report Date
    February 14, 2002
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HOSP LAB PERSONNEL REPORTED THAT THE PT CAME INTO THE ER IN CARDIAC ARREST. THE SUSPECT DEVICE WAS USED TO CHECK THE PT'S BLOOD GLUCOSE WHILE CPR AND LIFE SAVING MEASURES WERE BEING PERFORMED. THE SUSPECT DEVICE RESULT WAS 90 MG/DL. LATER WHILE STILL TRYING TO REVIVE THE PT ANOTHER BLOOD SAMPLE WAS DRAWN FROM A DIFFERENT SITE AND SENT TO THE LAB FOR A GLUCOSE VALUE. THIS RESULT WAS 390 MG/DL. NO TREATMENT FOR DIABETES IS ALLEGED. THE PT DID NOT RECOVER FROM THE CARDIAC ARREST AND EXPIRED. LEVEL 1 AND LEVEL 2 GLUCOSE CONTROLS WERE USED ON THE SUSPECT DEVICE SYSTEM AND BOTH CONTROLS FELL WITHIN THE ACCEPTABLE RANGE. THE SUSPECT DEVICE WAS REPLACED WITH NEW PRODUCT AND THEN AUTHORIZED FOR RETURN TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS CFR ROCHE DIAGNOSTICS NA 545686

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death