BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONETOUCH ULTRASMART TEST STRIPS

    MDR report key: 827115 · Received March 7, 2007

    Report

    Report Number
    MW1042173
    Event Type
    Other
    Date Received
    March 7, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 7, 2007
    Manufacturer
    LIFESCAN INC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SOMEONE COULD DIE. MAKE THEM USE SCREW TOP CAPS ON THEIR VIALS OF STRIPS! LIFESCAN MAKES ONETOCH ULTRASMART GLUCOSE MONITORING TEST STRIPS. LOT#2638903, EXP. 11/07. THE BOX CONTAINED TWO VIALS OF 25 STRIPS EACH. ONE VIAL WAS BAD, GIVING READINGS ABOUT 130 MG/DL HIGHER THAN THE ACCURATE VALUE. LIFESCAN SAID THAT STRIPS COULD AND DO "GO BAD" AFTER THREE MONTHS OF BEING OPENED DUE TO MOISTURE, ETC. STRIPS FROM BOTH VIALS WERE TESTED USING CONTROL SOLUTION. ONE VIAL WAS GOOD AND ONE VIAL WAS BAD - 130 MG/DL HIGH. BOTH VIALS CAME FROM THE SAME TAPED BOX OPENED AND USED IMMEDIATELY. CONTROL RANGE 105-140 MG/DL. THIS IS A LIFESCAN MFG PROBLEM. PROBABLY HAS TO DO WITH CLOSING THE LID ON THE VIAL TIGHTLY ENOUGH DURING PACKAGING. GET THEM TO FIX THE PROBLEM. SOMEONE COULD DIE. IF YOUR BLOOD SUGAR TESTS HIGHER THAN YOUR DESIRED 90-130 MG/DL RANGE, YOU TAKE MORE INSULIN TO LOWER IT. EVENTUALLY, THE BLOOD SUGAR DROPS SO LOW THAT DELIRIUM OR A COMA COULD OCCUR. DRIVING A CAR ANYONE? MY SUGAR LOW WAS VERY SEVERE, BUT I HAD ACCESS TO ORANGE JUICE TO BRING MY SUGAR BACK UP. I WAS LUCKY. DO YOU WANT THE BAD/GOOD TEST STRIPS OR SHOULD I RETURN THEM TO LIFESCAN?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRASMART TEST STRIPS GLUCOSE MONITOR STRIPS NBW LIFESCAN INC ULTRASMART 2638903

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other