BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1193099 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02559
    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
    MS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STIRPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER 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 THE ONE TOUCH ULTRA LINK METER DOES NOT TURN ON. THE PT DENIED EXPERIENCING ANY SYMPTOMS AND DID NOT RECEIVE ANY MEDICAL ATTENTION. THE PT DID NOT TAKE ANY ACTION REGARDING DIABETES TREATMENT DUE TO THE ISSUE. THE METER DID NOT TURN ON DURING THE TROUBLESHOOTING TELEPHONE CALL WHEN PRESSING THE POWER BUTTON OR INSERTING THE TEST STRIPS ALL THE WAY INTO THE TEST STRIP PORT. THE PT REPLACED THE BATTERY PER THE OWNER'S MANUAL. THE BATTERIES ARE CORRECTLY INSTALLED AND THE BATTERY CONTACTS ARE IN GOOD CONDITION. BASED ON THE INFO PROVIDED, THERE WAS NO MISUSE OF THE PRODUCT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING. THE PT DID NOT EXPERIENCE 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 2838857

    Patients

    Seq Age Sex Outcome Treatment
    1