BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1232083 · Received November 7, 2008

    Report

    Report Number
    2939301-2008-02997
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    November 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS HAVING THE FOLLOWING POWER RELATED ISSUE: METER DOES NOT TURN ON, WHICH WAS UNRESOLVED WITH TROUBLESHOOTING. THE PT STATED THAT THE SUBJECT METER FELL OUT OF CAR ONTO THE STREET AND THAT IS WHEN THE REPORTED ISSUE BEGAN. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2835003

    Patients

    Seq Age Sex Outcome Treatment
    1