BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 317113 · Received February 16, 2001

    Report

    Report Number
    2939301-2001-00157
    Event Type
    Malfunction
    Date Received
    February 16, 2001
    Report Date
    January 19, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT BACK TO BACK TESTS PERFORMED ON THE SS METER (WITHIN 10 MIN OF EACH OTHER USING SEPARATE FINGER STICKS) WERE 299 AND 130 MG/DL (79% DIFFERENCE). THE PT STATED THAT MOUTH WAS GETTING DRY. CONTROL SOLUTION TEST RESULT (144) WAS IN RANGE. LFS REP DISCOVERED PT DOES NOT CLEAN METER REGULARLY AND REVIEWED CLEANING AND USE OF CONTROL SOLUTION. THE METER WAS REPLACED. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6611 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other