BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH SURESTEP

    MDR report key: 654188 · Received December 12, 2005

    Report

    Report Number
    2939301-2005-05607
    Event Type
    Malfunction
    Date Received
    December 12, 2005
    Report Date
    December 7, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "240, 160, AND 115 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH SURESTEP GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA G277283A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR