BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 785265 · Received July 22, 2006

    Report

    Report Number
    1823260-2006-03809
    Event Type
    Malfunction
    Date Received
    July 22, 2006
    Date of Event
    July 11, 2006
    Report Date
    July 12, 2006
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE MEASURED 230, 180, 140, & 98 MG/DL BACK TO BACK. HOWEVER, MEMORY INDICATED RESULTS TAKEN WERE 218, 101, 111, AND 99 MG/DL. NO ACTIONS WERE TAKEN AND NO TREATMENT WAS REC'D REPORTEDLY AS A RESULT. 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 TEST STRIPS CFR ROCHE DIAGNOSTICS CORP. * 549117

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR SYNTHROID| DIOVAN| CRESTOR| POTASSIUM| ACCU-CHEK ADVANTAGE METER.| HYDROCHLOROT| FUROSEMIDE