BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1193098 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02560
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    September 26, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THERE WERE BLACK MARKS ON THE DISPLAY OF THE ONE TOUCH ULTRA LINK METER. THE PT DENIED HAVING ANY SYMPTOMS OR RECEIVING ANY MEDICAL ATTENTION. THE PT DID NOT TAKE ANY ACTION REGARDING DIABETES TREATMENT WITH REGARD TO THE ISSUE. THE PRODUCT WAS NOT NEW AND THE INTERFACE CABLE WAS NOT ATTACHED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DISPLAY ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PT DID NOT SUFFER ANY SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1