BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1220826 · Received October 30, 2008

    Report

    Report Number
    2939301-2008-02904
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Report Date
    October 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    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 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 OR 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 LFS ALLEGING THAT THE ULTRALINK METER READ HIGH. THE PT OBTAINED A 273 MG/DL ON THE ULTRALINK METER A 153 MG/DL ON THE ULTRA METER AND A 161 ON THE ONE TOUCH MINI METER. THE READINGS WERE BETWEEN 10-30 MINS FROM ONE ANOTHER. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. THE TEST STRIPS WERE IN GOOD CONDITION AND A QUALITY CONTROL TEST WAS DONE AND THE TEST STRIPS FELL OUT OF RANGE USING THE CONTROL SOLUTION. METER AND TEST STRIPS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2867727

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR