BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE TEST STRIP 100

    MDR report key: 1981269 · Received February 2, 2011

    Report

    Report Number
    MW5019289
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ABBOTT
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAS TESTED REPEATED DURING DIFFERENT TIMES PER DAY AFTER MEALS/FASTING AND CONTINUES TO GET A READING OF 96. PT HAS PROPERLY STORED MEDS AS WELL AS REPLACED BATTERIES IN MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE TEST STRIP 100 TEST STRIP NBW ABBOTT 1070305

    Patients

    Seq Age Sex Outcome Treatment
    1