BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA TEST STRIPS 100'S

    MDR report key: 1052135 · Received May 23, 2008

    Report

    Report Number
    MW5007016
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    May 15, 2008
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ILLEGALLY RELABELED/REPACKAGED ONE TOUCH ULTRA TEST STRIPS. WE HAVE 1 BOX OF EACH OF THE LOTS LISTED. LOT 2762181 EXP 03/2009 BOX OF 100. LOT 2771567 EXP 04/2009 BOX OF 100. PER LIFESCAN INSTRUCTIONS WE ARE NOTIFYING YOU OF THE PRODUCT ON HAND. ITEMS RECEIVED FROM STOP AND SHOP WAREHOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA TEST STRIPS 100'S NONE NBW LIFESCAN 2762181
    2 ONE TOUCH ULTRA TEST STRIPS 100'S NONE NBW LIFESCAN 2771567

    Patients

    Seq Age Sex Outcome Treatment
    1