BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1232765 · Received November 14, 2008

    Report

    Report Number
    1823260-2008-08420
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE OF 146 MG/DL, 409 MG/DL, AND 122 MG/DL WITHIN 10 MINUTES ON THE AVIVA 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.

    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 300896

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LISINOPRIL-HCTZ 20/12.5 MG/DAY - 1 YEAR| ACTOS 30 MG/DAY - 1 YEAR| SIMVASTATIN 40 MG/DAY - 1 YEAR| TRICOR 145 MG/DAY - 1 YEAR