BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 277997 · Received May 11, 2000

    Report

    Report Number
    2939301-2000-00411
    Event Type
    Malfunction
    Date Received
    May 11, 2000
    Report Date
    April 16, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES DOING BACK TO BACK BLOOD GLUCOSE TESTS WITHIN 10 MINUTES, USING SEPARATE FINGER STICKS. RPTR'S RESULTS WERE 74, 101, 104, 88 AND 132 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. NO HARM WAS ALLEGED. FOLLOW-UP ATTEMPTS TO CONTACT THE RPTR FOR ADD'L INFO HAVE NOT BEEN SUCCESSFUL.

    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 UNKNOWN Other