BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1193100 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02558
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    September 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 CONTROL SOLUTION TEST FELL OUTSIDE SPECIFICATIONS ON THE ONE TOUCH ULTRA LINK METER. THE PT DID NOT ALLEGE ANY SYMPTOMS AND DID NOT MENTION SEEKING ANY MEDICAL ATTENTION DUE TO THE ISSUE. THE PT DID NOT MENTION TAKING ANY ACTION REGARDING DIABETES TREATMENT WITH REGARD TO THE ISSUE. THE RESULTS REPORTED WERE 143 AND 146 MG/DL FOR A TEST STRIP VIAL WITH A CONTROL SOLUTION RANGE OF 94-126 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGED THE CONTROL SOLUTION TEST RESULTS FELL OUTSIDE THE RANGE BASED ON THE TEST STRIP VIAL. THE PT DID NOT SUFFER ANY INJURY AND DID NOT SEEK ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2841334

    Patients

    Seq Age Sex Outcome Treatment
    1