BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 336077 · Received May 31, 2001

    Report

    Report Number
    2939301-2001-00507
    Event Type
    Malfunction
    Date Received
    May 31, 2001
    Report Date
    April 28, 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

    THE PATIENT REPORTED BACK TO BACK TESTS ON THEIR SURESTEP METER OF 142, 107 AND 111 MG/DL RESPECTIVELY (29% DIFFERENCE). PT COULD NOT RECALL IF SEPARATE FINGER STICKS WERE USED FOR THE COMPARISON. NO ALLEGATION OF HARM. A CONTROL SOLUTION TEST PERFORMED ON THE METER WITH NEW CONTROL SOLUTION FELL WITHIN RANGE 120 (101-152).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25113 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other