BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1243226 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08263
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 25, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A "LO" (LESS THAN 10 MG/DL) ON THE ACCU-CHEK ACTIVE S SYSTEM. THE CUSTOMER DRANK ORANGE JUICE. FIVE MINUTES AFTER THE "LO" (LESS THAN 10 MG/DL) RESULT; THE CUSTOMER OBTAINED THE BLOOD GLUCOSE RESULT OF 86 MG/DL (SAME SYSTEM). THE CUSTOMER FELT SHAKY WITH THE "LO" (LESS THAN 10 MG/DL) AND THE 86 MG/DL BLOOD GLUCOSE RESULTS. THE CUSTOMER DID NOT DISCLOSE WHEN SHE FELT BETTER. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22989631

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR NO DIABETES MEDICATION| SYNTHROID