BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2280793 · Received October 6, 2011

    Report

    Report Number
    2939301-2011-09899
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Report Date
    March 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED LIFESCAN TO REPORT MANY UNSPECIFIED ERROR MESSAGES. THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3041177

    Patients

    Seq Age Sex Outcome Treatment
    1