BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1771184 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01249
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 296 MG/DL BACK TO BACK WITH A RESULT OF 98 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED SHE SELF TREATED WITH FOOD; HOWEVER, NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 300971

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PREDNISONE - TIME AND DOSE UNK - THREE TIMES DAILY