BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 5090702 · Received September 16, 2015

    Report

    Report Number
    MW5056266
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 16, 2015
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I TEST MY GLUCOSE ROUTINELY (PREDIABETES.) ON (B)(6) 2015, I TESTED MY GLUCOSE WITH A TEST STRIP FROM A NEW VIAL OF ONETOUCH ULTRA LOT NUMBER 3684072, EXPIRATION 03/2016. IT WAS 159. IT IS USUALLY 90-110. I CONTINUED TO TAKE IT THROUGHOUT THE DAY - 182, 148, 188, 158, 167, 158, 155, 186, 166, 170, 186, 170, 179. THEN I USED A TEST STRIP FROM A DIFFERENT VIAL. IT WAS 100. I IMMEDIATELY TRIED THE TEST STRIP FROM THE FIRST VIAL - 158. I DID AN INTERNET SEARCH TO SEE IF TEST STRIPS COULD BE BAD. I CALLED A FRIEND WITH DIABETES. I TOOK THE TWO TEST STRIP VIALS (DIFFERENT LOT NUMBERS) TO HER HOUSE AND WE USED CONTROL SOLUTION TO TEST; 163 IN THE FIRST VIAL, AND 88 IN THE SECOND VIAL. I CALLED ONE TOUCH. THEY TOOK ALL THIS INFO AND HAD ME TEST FOLLOWING EXACT DIRECTION FROM AS TO HOW TO USE THE CONTROL SOLUTION. THE RESULT WAS 169. THEY CONFIRMED THIS WAS A BAD BATCH. THE VIALS HAVE BEEN STORED IN A CLOSED CLOSET IN AN AIR CONDITIONED HOUSE. THEY SENT REPLACEMENT VIALS AND I RETURNED THE BAD VIALS (TWO OF THE SAME LOT NUMBER) TO THEM TODAY BY (B)(6) MAIL. I REPORTED THIS INFO YESTERDAY TO (B)(4), THE SUPPLIES OF THE TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614437 ONE TOUCH ULTRA ONE TOUCH ULTRA TEST STRIPS NBW LIFESCAN C25 3684072
    614438 ONE TOUCH ULTRA ONE TOUCH ULTRA TEST STRIPS NBW LIFESCAN 3684072

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR