BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1070097 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05157
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 28, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACTIVE S SYSTEM WITHIN 10 MINUTES: 293 MG/DL, 216 MG/DL, 135 MG/DL, AND 123 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING STRIP - LFR LFR ROCHE DIAGNOSTICS 22972331

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR PREDNISONE 0.05MG IN AM 3-4 YEARS| FLEXERIL IN AM - 4 YEARS| DIOVAN 80MG IN AM - 3-4 YEARS| LEVOXYL 0.05MG IN AM - 2 YEARS| HUMALOG 3 YEARS| COLCHINCINE 0.6MG AM & PM - 2 YEARS| LANTUS 50UNITS BEFORE BEDTIME 3 YEARS