BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1071471 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01299
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 THE EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A PATIENT ALLEGED THAT HER ONETOUCH ULTRALINK RESULTS WERE OUT OF RANGE WITH CONTROL SOLUTION, 88-117, RESULT 130 MG/DL. BECAUSE THE PATIENT HAD NO TEST STRIPS, THE COMPLAINT COULD NOT BE RESOLVED AND THE PRODUCTS WERE REPLACED. THE PATIENT HAD NO SYMPTOMS NOR RECEIVED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2818256

    Patients

    Seq Age Sex Outcome Treatment
    1