BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1211375 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07799
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE AVIVA SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 146 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. ALSO REPORTED RESULTS OF "250'S" AND "120'S" 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 301232

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR PRANDIN - 6 MG/DAY - 2 MONTHS| HUMALOG SLIDING SCALE - 2 MONTHS| NPH INSULIN - 32 UNITS/DAY - 1 MONTH