BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE 100 TEST STRIPS

    MDR report key: 2182352 · Received July 25, 2011

    Report

    Report Number
    MW5021516
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    August 8, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I READ THE REPORT ON THE TEST STRIPS THAT WERE RECALLED BY ABBOTT INC. THE PRODUCTS THEY RECALLED WERE NOT THE ONES I HAD PROBLEMS WITH. I USE THEIR FREE STYLE STRIPS (I DON'T HAVE THE LOT NUMBERS FOR THE EARLY ONES, THESE ARE THE LOT NUMBERS I HAVE NOW: LOT NUMBERS #1016922 AND #1012315). MY READINGS WERE NOT LOW, THEY WERE VERY HIGH. THIS STARTED IN (B)(6), WHEN MY READINGS WENT FROM A LOT OF LOWS TO VERY VERY HIGH. I SEE MY DOCTOR EVERY MONTH, AND SHE ASKED ME "WHY MY READINGS WERE SO HIGH." UNTIL NOW I COULD NOT FIGURE THIS OUT. NOTE: ON (B)(6), MY BLOOD SUGAR WAS 417, I TOOK IT AGAIN ONE HOUR LATER AND THIS TIME IT WAS 375, I TOOK IT AGAIN IN 2 HOURS AND IT WAS 253. FROM THE FIRST READING TO THE LAST ONE THAT DAY, I WAS STILL ON A FAST. WHAT REALLY UPSETS ME, I CALLED ABBOTT SEVERAL MONTHS AGO ABOUT THIS PROBLEM. I TOLD THE LADY I TALKED TO THAT MY READINGS HAD GONE UP TO HIGH, SHE TOLD ME I WAS TAKING THE READINGS WRONG, AND TO RUN ANOTHER TEST ON A FAST. I TOLD HER AGAIN I WAS ON A FAST AND THE READINGS WERE JUST AS HIGH. SHE TOLD ME THERE WAS NOTHING THEY COULD DO FOR ME. I ASKED HER IF IT COULD BE THE MACHINE PROBLEM, AND COULD I SEND THIS ONE BACK AND GET A NEW METER. SHE TOLD ME IT WASN'T A METER PROBLEM, AND AGAIN THERE WAS NOTHING THEY COULD DO ABOUT IT. I AM DISABLED AND ONLY HAVE MEDICAL, THEY ONLY COVER ONE METER AND I CAN'T AFFORD TO BUY A SECOND METER. I AM IN A (B)(6), AND THE ONLY WAY I HAVE OUT IS TO STOP TAKING MY BLOOD READINGS ON THEIR MACHINE. THANK YOU FOR YOUR TIME, (B)(6). DATE OF USE: 1995 TO NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE 100 TEST STRIPS TEST STRIPS NBW ABBOTT DIABETES CARE INC. 1012315
    2 FREESTYLE 100 TEST STRIPS TEST STRIPS NBW ABBOTT DIABETES CARE INC. 1016922
    3 FREESTYLE FREEDOM METER LFR ABBOTT DIABETES CARE INC. FREESTYLE FREEDOM

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other