BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1002666 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01384
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY REC'D BLOOD GLUCOSE RESULTS OF 719 AND 619 MG/DL. THE RESULTS ARE OUTSIDE THE NUMERIC RANGE OF 10-600 MG/DL OF THE DEVICE. 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 BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR NOVOLIN 70/30 90 UNITS AM| MOTRIN 600MG 2/DAY| OVOLIN R SLIDING SCALE| NOVOLIN N 70 UNITS IN EVENING| LASIX 20MG 1/DAY| GLUCOPHAGE 1000MG 2/DAY| SIMVASTATIN 40 MG AT BEDTIME| ACTOS 10MG 2/DAY| "ACULATE" 20MG 2/DAY| NIFEDIPINE XL 90MG 1/DAY