BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1063818 · Received June 19, 2008

    Report

    Report Number
    2939301-2008-01146
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRALINK METER WAS GIVING INACCURATELY HIGH READINGS WITH THE CONTROL SOLUTION. THE PT OBTAINED THE CONTROL SOLUTION RESULT OF 139 MG/DL. THE ACCEPTABLE RANGE FOR THE LOT OF TEST STRIPS IN USE WAS 103 MG/DL TO 138 MG/DL. THE CUSTOMER CARE ADVOCATE DETERMINED DURING THE CALL THAT THE PT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING, THE PT'S TESTING TECHNIQUE WAS CORRECT AND THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE AND CALIBRATION CODE NUMBER. THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DID NOT SEEK ANY MEDICAL ATTENTION. THE TEST STRIPS WERE REPLACED. THE PT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PT EXPERIENCED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE CONTROL SOLUTION TEST RESULT WAS OUT OF RANGE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2799840

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown