BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE A1C TEST

    MDR report key: 578968 · Received March 1, 2005

    Report

    Report Number
    MW1034804
    Event Type
    Malfunction
    Date Received
    March 1, 2005
    Report Date
    March 1, 2005
    Manufacturer
    BRISTOL-MYERS SQUIBB COMPANY
    Product Code
    KQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AD FOR CHOICE A1C TEST SAID THAT A !% REDUCTION IN A1C LOWERS THE RISK OF EYE, KIDNEY, AND NERVE DAMAGE BY 37%. RPTR BELIEVES IT SHOULD SAY A ONE PERCENTAGE POINT REDUCTION WOULD HAVE THIS IMPACT. THE AD COPY IS ERRONEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE A1C TEST HOME HGB A1C TEST MACHINE KQE BRISTOL-MYERS SQUIBB COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other