BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING METER

    MDR report key: 1203704 · Received October 9, 2008

    Report

    Report Number
    2939301-2008-02616
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Report Date
    October 6, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT HAD BLACK MARKS ON THE DISPLAY, MAKING IT DIFFICULT TO READ THE DISPLAY. THE DISPLAY ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1