BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP ENHANCED

    MDR report key: 393109 · Received April 29, 2002

    Report

    Report Number
    2939301-2002-05776
    Event Type
    Malfunction
    Date Received
    April 29, 2002
    Report Date
    April 24, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A SURESTEP ENHANCED METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 75 MG/DL, "200+" MG/DL (IN THE REPORTED ISSUE NOTES IT WAS DOCUMENTED AS "200+" AND USED 201 MG/DL). TESTS WERE DONE WITHIN < 10 MINUTES WITH A DIFFERENCE OF 81%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED. NOTE - CUSTOMER CLEANING METER INCORRECTLY. IN THE REPORTED ISSUE NOTES IT WAS DOCUMENTED THAT, "THE CONTROL SOLUTION RESULT WAS WITHIN RANGE, C143 (100-151)".

    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 49 YR