BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 418323 · Received September 18, 2002

    Report

    Report Number
    2939301-2002-09693
    Event Type
    Malfunction
    Date Received
    September 18, 2002
    Report Date
    September 15, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A LIFESCAN METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 190, 269, 191 MG/DL. TESTS WERE DONE WITHIN 11-20 MINUTES WITH A DIFFERENCE OF 22%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR