BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1772062 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09524
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    August 6, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 541 MG/DL, 208 MG/DL, AND 135 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 AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300763

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR ASPIRIN DOSE UNK 1/DAY- FOR YEARS| PLAVIX DOSE UNK 1/DAY - FEW MONTHS| AVARDO 150 MG 1/DAY - 4 MONTHS| AVARDO 350 MG 1/DAY - 4 MONTHS| ULCER MEDICATION UNK - MANY YEARS