BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA TEST STRIPS

    MDR report key: 1303354 · Received December 2, 2008

    Report

    Report Number
    MW5009849
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PT HAD PROBLEMS TESTING WITH TEST STRIPS FROM ONE VIAL; PT HAS BEEN DIABETIC FOR A LONG TIME PER HUSBAND. HUSBAND STATES WHEN SHE OPENED A NEW BOX, THERE WAS NO PROBLEM. ONLY ONE OUT OF THE 4 VIALS FROM BOX LOT #2851236- EXP 01/2010- ONE TOUCH ULTRA TEST STRIPS WERE AFFECTED: THE TEST STRIPS WOULD NOT DRAW UP THE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA TEST STRIPS LIFESCAN NBW LIFESCAN 2851236

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR