BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761290 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06344
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 549428, EXPIRATION DATE 01/31/2008). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 432 MG/DL AND 155 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. TWO ADVANTAGE SYSTEMS WERE USED DURING THE COMPARISONS; IT IS UNKNOWN WHICH SYSTEM PRODUCED THE DISCREPANT RESULT. REQUESTED RETURN OF SUSPECT DEVICE 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 549428

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR OMEPRAZOLE - 20MG ONCE DAILY - 5 YEARS| ADVAIR - 250MG 1 PUFF 2/DAY - 5 YEARS| ASPIRIN - 81MG ONCE DAILY - 2 YEARS| FLAVIX - 75MG ONCE DAILY - 2 YEARS| ZOCOR - 20MG ONCE DAILY - 2 YEARS| FOSAMAX - 75MG 1/WEEK - 5 YEARS| ISOSORBIDE MONONITRATE - 60MG - 2 YEARS| ETHACRYNIC ACID - 25MG 1/DAILY - 7 MONTHS| SYNTHROID - 0.175 ONCE DAILY - 58 YEARS| MICARDIS - 40MG ONCE DAILY - 2 YEARS| METOPROLOL - 200MG ONCE DAILY - 2 YEARS| LANTUS - 30UNITS ONCE DAILY - 5 YEARS