BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP ORIGINAL

    MDR report key: 398007 · Received March 22, 2002

    Report

    Report Number
    2939301-2002-04187
    Event Type
    Malfunction
    Date Received
    March 22, 2002
    Report Date
    March 7, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A SS METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 161, 124, 191, 124MG/DL. TESTS WERE DONE WITHIN 10 MINS WITH A DIFFERENCE OF 22%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR