BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1171425 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06943
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    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 280MG/DL ON THE AVIVA SYSTEM WHILE A PROFESSIONAL DEVICE PRODUCED A RESULT BETWEEN 75MG/DL AND 140MG/DL. AN ADDITIONAL COMPARISON REPORTED RESULTS OF 130MG/DL ON THE AVIVA SYSTEM AND 70MG/DL ON THE PROFESSIONAL DEVICE WITH 10 MINS. INFO PROVIDED INDICATES THE CUSTOMER INJECTED AN UNK TREATMENT BASED ON THE PROFESSIONAL DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER STRIPS ARE UNAVAILABLE FOR RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK