BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE STYLE LITE

    MDR report key: 2560680 · Received April 30, 2012

    Report

    Report Number
    MW5025254
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    April 29, 2012
    Report Date
    April 30, 2012
    Manufacturer
    ABBOTT
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ABBOTT FREESTYLE LITE TEST STRIPS, LOT 1251734, 2013/07 EXPIRATION DATE, CODE 16. THIS IS A TUBE OF 50 TEST STRIPS. TUBE IS ALWAYS KEPT TIGHTLY SEALED. THIS TUBE HAS AN ABNORMALLY HIGH ERR RATE - METER RECORDS ERR FOLLOWED BY A NUMBER THAT I HAVEN'T TRACKED. MY EXPERIENCE IS HIGHER THAN 10% (>5 FAILED TESTS) FROM THIS LOT. MY ATTEMPTS TO CONTACT THE MFR, ABBOTT FAILED TWICE ON (B)(6) WHEN I CALLED THEIR (B)(4). I WAS ABLE TO REACH AN OPERATOR AT THE SECOND NUMBER WHO TRIED TO GET ME IN CONTACT WITH SOMEONE BUT THIS ALSO FAILED. DOSE OR AMOUNT: ONE TEST, FREQUENCY: 4 TO 6/DAY. ROUTE: CUTANEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE STYLE LITE GLUCOSE TEST STRIPS NBW ABBOTT 1251734

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR