BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 312941 · Received January 11, 2001

    Report

    Report Number
    2939301-2001-00032
    Event Type
    Malfunction
    Date Received
    January 11, 2001
    Report Date
    December 13, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT BACK TO BACK TESTS PERFORMED ON THEIR FAMILY MEMBER'S SURESTEP METER (USING THE SAME FINGER STICK) WERE 113, 123, 133 AND 143 MG/DL (21% DIFFERENCE). ON FOLLOW-UP, THE REPORTER STATED THAT THEIR FAMILY MEMBER HAS DIFFICULTY GETTING ENOUGH BLOOD TO APPLY TO THE TEST STRIP, BUT THE METER IS WORKING "FINE". NO SYMPTOMS WERE REPORTED. THE METER IS NOT CLEANED ON A REGULAR BASIS. LFS REP REVIEWED QC PROCEDURES AND DISCUSSED WAYS TO GET A BETTER BLOOD SAMPLE. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other