BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 317908 · Received February 24, 2001

    Report

    Report Number
    2939301-2001-00172
    Event Type
    Malfunction
    Date Received
    February 24, 2001
    Report Date
    January 25, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORT BACK TO BACK TESTS PERFORMED (WITHIN 10 MINUTES) ON THEIR SS METER USING SEPARATE FINGER STICKS WERE 173, 151 AND 133 MG/DL (26% DIFFERENCE). NO SYMPTOMS WERE REPORTED. CONTROL SOLUTION TEST WAS IN RANGE. ON FOLLOW-UP, PT CONFIRMED THE ABOVE INFORMATION AND SAID THEY WERE COMFORTABLE WITH THEIR METER. LFS REP REVIEWED IMPORTANCE OF CLEANING METER AND USING CONTROL SOLUTION. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7508 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other