BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 331295 · Received May 2, 2001

    Report

    Report Number
    2939301-2001-00396
    Event Type
    Malfunction
    Date Received
    May 2, 2001
    Report Date
    April 3, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT THE PT OBTAINED BACK TO BACK SURESTEP READINGS OF 400 AND 40. JNO SYMPTOMS WERE REPORTED. ON FOLLOW-UP, PATIENT'S FAMILY MEMBER CONFIRMED BACK TO BACK TESTS WERE DONE WITH DIFFERENT FINGER STICKS. A REPLACEMENT METER WAS SENT TO PT. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20375 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other