BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1083630 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05829
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 27, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 76MG/DL ON THE AVIVA SYSTEM AND 33 MG/DL ON A PROFESSIONAL DEVICE WITHIN 10 MINUTES. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 200993

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK