BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1834195 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07911
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) IS K073231.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT'S PHARMACIST CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS UNKNOWN ERROR MESSAGE. THE PHARMACIST DOES NOT REMEMBER WHICH ERROR # WAS DISPLAYED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING SINCE THE PHARMACIST DID NOT HAVE THE PRODUCTS AVAILABLE. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1