BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 1885230 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06399
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 20, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA BLOOD GLUCOSE RESULTS OF 300 MG/DL, 260 MG/DL, AND 130 MG/DL WITHIN 5 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTED DEVICE WAS IMPROPERLY POSITIONED. DEVICE REVISION SURGERY WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 302377

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR INSULIN (UNSURE OF WHAT TYPE)| WHEELCHAIR| INTERNAL DEFIBRILLATOR