BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1032524 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03452
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS SHE WAS "OUT OF IT" WITH BLOOD GLUCOSE RESULT OF 500 MG/DL OBTAINED ON THE AVIVA SYSTEM. CUSTOMER WAS RE-TESTED WITHIN 10 MINUTES ON THE SAME SYSTEM, AND RESULT WAS 100-SOMETHING (MG/DL). PARAMEDICS TESTED THE CUSTOMER ON THEIR METER WITHIN 10 MINUTES OF RESULT OF 100-SOMETHING (MG/DL), AND RESULT WAS 46 MG/DL. CUSTOMER WAS TREATED WITH "SUGAR WATER" AND WAS HOSPITALIZED. 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 300973

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization HUMALOG PUMP