BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1162864 · Received September 9, 2008

    Report

    Report Number
    2939301-2008-02043
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/ PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS HAVING THE FOLLOWING POWER RELATED ISSUE: "DISPLAY FROZEN" AND THE FOLLOWING BUTTONS/ SCANNERS ISSUE: "OK BUTTON, UP ARROW BUTTON AND DOWN ARROW BUTTONS ARE NOT RESPONDING." THE REPORTED ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2834522

    Patients

    Seq Age Sex Outcome Treatment
    1