BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP ENHANCED

    MDR report key: 392873 · Received May 3, 2002

    Report

    Report Number
    2939301-2002-05915
    Event Type
    Malfunction
    Date Received
    May 3, 2002
    Report Date
    April 29, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPROTED EXPERIENCING INACCURATE HIGH RESULTS WITH A SURESTEP ENHANCED METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 393, 222, 187, 128, 234, 500MG/DL. TESTS WERE DONE WITHIN MINUTES WITH A DIFFERENCE OF 53%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR