BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 306792 · Received November 29, 2000

    Report

    Report Number
    2939301-2000-00994
    Event Type
    Malfunction
    Date Received
    November 29, 2000
    Report Date
    July 19, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT BACK TO BACK TESTS PERFORMED ON THE SURESTEP METER WERE 241, 164, 160 AND 156 MG/DL (47% DIFFERENCE). NO SYMPTOMS WERE REPORTED. THERE WAS NO ALLEGATION OF HARM.

    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 UNKNOWN Other