BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE TEST STRIPS

    MDR report key: 1970114 · Received January 19, 2011

    Report

    Report Number
    MW5019099
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ABBOTT
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MOTHER SAYS THAT THE NEW FREESTYLE TEST STRIPS WITH BUTTERFLY DESIGN CAUSES SON'S READINGS TO BE LOWER AND THE CODING IS NOT CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE TEST STRIPS TEST STRIPS LFR ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1