BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1063877 · Received June 19, 2008

    Report

    Report Number
    2939301-2008-01150
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET REC'D 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/REPORTER, THE PT'S MOTHER, CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRALINK METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE PT REPORTED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, NOR ANY MEDICAL ATTN. THE PT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PT REPORTED NO SYMPTOMS OR ANY MEDICAL ATTN. HOWEVER, AS THE PT OBTAINED AN UNSPECIFIED ERROR MESSAGE, 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 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1