BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083898 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05822
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULT OF 446 MG/DL, 129 MG/DL AND 236 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER ALLEGED THAT AT ANOTHER TIME, THE CUSTOMER OBTAINED BACK TO BACK READINGS OF 440 MG/DL AND 94 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549960

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR PREDNISONE - 1YEAR| NOVOLOG - 1 YEAR - 20 UNITS DAILY| LANTUS - 1 YEAR - 50 UNITS DAILY