BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 307373 · Received December 1, 2000

    Report

    Report Number
    2939301-2000-01097
    Event Type
    Malfunction
    Date Received
    December 1, 2000
    Report Date
    November 5, 2000
    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

    PATIENT REPORTED THAT BACK TO BACK TESTS PERFORMED ON PT'S SURESTEP METER WERE 200, 167 AND 154 MG/DL (26% DIFFERENCE). PT WAS FEELING DROWSY AND THIRSTY AT THE TIME TESTS WERE DONE. THE METER IS NOT CLEANED ACCORDING TO MANUFACTURER'S PRODUCT RECOMMENDATIONS. 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