BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781001 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06563
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 19, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 214 MG/DL ON THE INFORM SYSTEM AND 96 MG/DL ON A LAB DRAWN WITHIN 10 MINUTES. NO ACTION TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR NBW ROCHE DIAGNOSTICS 549730

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR FOLIC ACID| MAGNESIUM SULFATE| D5 - 1 AMP/ADMISSION| VITAMINS| THIAMINE| D50 - NP 0.5 AMP 2 HRS AFTER ADMISSION