BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESCAN ONE TOUCH ULTRA

    MDR report key: 1393844 · Received May 25, 2009

    Report

    Report Number
    MW5011217
    Event Type
    Malfunction
    Date Received
    May 25, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 25, 2009
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED FROM WHOLESALER GLUCOSE TEST STRIPS LABELED LOT 2871217. ALSO POSSIBLE DIVERTED PRODUCT LOT # 2871217. ALSO POSSIBLE DIVERTED PRODUCT LOT # 2871217 WITH NO NDC NUMBER. PRODUCT WAS RETURNED TO THE WHOLESALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESCAN ONE TOUCH ULTRA GLUCOSE TEST STRIPS NBW LIFESCAN ONE TOUCH ULTRA 2871217
    2 LIFESCAN ONE TOUCH ULTRA GLUCOSE TEST STRIPS NBW LIFESCAN ONE TOUCH ULTRA 2799987

    Patients

    Seq Age Sex Outcome Treatment
    1