BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1182049 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07088
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULT OF 216 MG/DL AND 98 MG/DL WITHIN 10 MINUTES ON PROFESSIONAL SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT. ALSO, CUSTOMER STATES THE USE BY DATE ON THE AVIVA TEST STRIP VIAL LABEL IS 07/2009; MANUFACTURER'S BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 05/31/2009. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF PRODUCT, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300956

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK