BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESCAN

    MDR report key: 6290059 · Received January 27, 2017

    Report

    Report Number
    MW5067557
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    January 14, 2017
    Report Date
    January 14, 2017
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ONE TOUCH ULTRA TEST STRIP LOT #4030763 USED TEST STRIP TO TEST BLOOD SUGAR UPON WAKING UP. LEVEL SHOWED 241, ABOUT 120 ABOVE NORMAL. IF I HAD USED THE RECOMMENDED INSULIN DOSE TO BRING DOWN THE READING, THE BLOOD SUGAR WOULD HAVE CRASHED, POSSIBLY CAUSING COMA. JUST TO CHECK THINGS BECAUSE THIS WAS A BRAND NEW BOX OF TEST STRIPS, A SECOND TEST WAS RUN USING AN OLDER LOT. THIS TIME THE EXPECTED READING OF 100 TO 120 WAS FOUND. NO ADDITIONAL INSULIN WAS NEEDED. I FEAR TO THINK THAT IF I HAD ACTED ON THE ORIGINAL READING, BAD THINGS COULD HAPPEN. MY BODY WOULD NOT HAVE BEEN DISCOVERED FOR A WEEK OR MORE. IN THE PAST, THE TEST STRIPS HAVE WORKED AS THEY SHOULD. DOSE OR AMOUNT: 1. FREQUENCY: 4X PER DAY. ROUTE: FINGER PRICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67821 LIFESCAN ONE TOUCH ULTRA TEST STRIP NBW LIFESCAN 4030763

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening