BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE STEP PRO

    MDR report key: 1203773 · Received September 26, 2008

    Report

    Report Number
    1203773
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    THE DEFECTIVE TEST STRIPS HAVE A BLACK BAND ON THE SAME SIDE OF THE TEST STRIP THAT HAS THE PINK APPLICATION SQUARE. A BLACK BAND SHOULD NOT BE PRESENT ON THAT SIDE OF THE TEST STRIP. THE TEST PAD ON THE DEFECTIVE TEST STRIPS WILL EITHER BE MISSING OR VERY LOOSELY ATTACHED. THE CONFIRMATION DOT ON THE BACK OF THE TEST STRIP MAY ALSO BE OFF CENTER. LIFESCAN HAS BEEN NOTIFIED AND HAS ACKNOWLEDGED THE PROBLEM. AS OF THE END OF SEPTEMBER THERE HAS BEEN NO RESOLUTION.====================== MANUFACTURER RESPONSE FOR TEST STRIP, BLOOD GLUCOSE, SURE STEP PRO======================A VOICE MAIL WAS LEFT FOR THE REP. WE HAVE NOT HEARD BACK FROM THEM YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE STEP PRO TEST STRIP, BLOOD GLUCOSE NBW LIFESCAN, INC. * 2860185 008

    Patients

    Seq Age Sex Outcome Treatment
    1 *