BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1162375 · Received September 9, 2008

    Report

    Report Number
    2939301-2008-02099
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE STRIPS DO 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 CONTROL SOLUTION TEST WAS FALLING ABOVE THE INDICATED CONTROL RANGE. DURING TROUBLESHOOTING, THE PATIENT DID NOT HAVE THE SUBJECT METER WITH HER; HOWEVER, THE PATIENT INFORMED THE CUSTOMER CARE ADVOCATE THAT SHE PERFORMED A CONTROL SOLUTION TEST WITH A NEW VIAL OF TEST STRIPS AND THE RESULT FELL WITHIN THE SPECIFIED CONTROL SOLUTION RANGE. 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 2834259

    Patients

    Seq Age Sex Outcome Treatment
    1