BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1232178 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02946
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Report Date
    October 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVAL, BUT HAS NOT YET RECEIVED IT. 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

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THERE WAS A DELAYED RESPONSE WHEN PRESSING THE OK BUTTON ON THE ONE TOUCH ULTRA LINK METER. THE PT DID NOT SUFFER ANY SYMPTOMS AND DID NOT TAKE ANY ACTION REGARDING TREATMENT DUE TO THE ISSUE. THE PT DENIED SEEKING MEDICAL ATTENTION. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THERE WAS NO MISUSE OF THE PRODUCT BASED ON THE INFO PROVIDED. THE ISSUE WAS NOT INTERMITTENT AND THE PRODUCT WAS NOT NEW (CUT OF BOX). THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PT DID NOT SUFFER ANY 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 2846056

    Patients

    Seq Age Sex Outcome Treatment
    1