BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 282637 · Received June 16, 2000

    Report

    Report Number
    2939301-2000-00507
    Event Type
    Malfunction
    Date Received
    June 16, 2000
    Report Date
    May 19, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER DID BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TESTS, USING THE SAME FINGER STICK. REPORTER RESULTS WERE 126, 190, 187 AND 129MG/DL. REPORTER FELT DOWN WHEN REPORTER TAKES THE MEDICATION. A CONTROL TEST WAS IN RANGE, 114 (87-131). ON FOLLOW-UP, THE REPORTER BRIEFLY CHECKS THE CONFIRMATION DOT TO VERIFY BLUE DOT WHEN TESTING, AND DESCRIBED AN ACCURATE TECHNIQUE FOR APPLYNG BLOOD TO THE TEST STRIP. NO HARM WAS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other