BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE TEST STRIPS

    MDR report key: 2018250 · Received March 8, 2011

    Report

    Report Number
    MW5019736
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2010
    Report Date
    March 8, 2011
    Manufacturer
    ABBOTT
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH NEW FREESTYLE AND FREESTYLE LITE TEST STRIPS. FREESTYLE FLASHMETER (B)(4), TEST STRIPS LOT 1032419, EXP 2012/05, #50, CODE 16. THESE TESTED TOO LOW -81 AND 82- WITH FREESTYLE CONTROL SOLUTION (B)(4), EXP 2012/07. WHEN I REPORTED THE PROBLEM TO THE COMPANY, I WAS TOLD THAT THE NEW TEST STRIPS USE AN ENZYMATIC PROCESS AND ARE NOT MEASURING THE TOTAL GLUCOSE AND TO CONTACT MY DOCTOR. WHAT IS HE GOING TO DO ABOUT FAULTY TEST STRIPS? I ALSO TRIED MY FREESTYLE LITE METER (B)(4) WITH OLD STYLE STRIPS LOT 1010935, EXP 2012/04 ON MYSELF AND GOT A FASTING OF 147. NEW STRIPS LOT 1073207, EXP 2012/02 #10 CODE 16 TESTED ON THE SAME DROP OF BLOOD WAS 112. YOU CAN SEE THAT THERE IS A VAST DIFFERENCE IN THE TWO READINGS. THE FIRST ONE, 147 IS ONE THAT I WOULD FEEL THAT I HAD TO TAKE SOME ACTION WITH DIET, EXERCISE, OR MEDICATION. WITH THE SECOND, 112, I WOULD THINK EVERYTHING IS FINE. PLEASE LOOK INTO THIS AND MAKE THEM CORRECT THE NEW TEST STRIPS OR GO BACK TO SELLING THE OLD ONES WHICH WERE WITHIN 4-6 UNITS OF MY LAB REPORTS. DATES OF USE: (B)(6) 2009 - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE TEST STRIPS TEST FASTING GLUCOSE LEVEL NBW ABBOTT 1032419
    2 FREESTYLE LITE TEST STRIPS TEST FASTING GLUCOSE LEVEL NBW ABBOTT 1073207

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR