BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 279882 · Received May 26, 2000

    Report

    Report Number
    2939301-2000-00458
    Event Type
    Malfunction
    Date Received
    May 26, 2000
    Report Date
    May 1, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES DOING BACK TO BACK BLOOD GLUCOSE TESTS, USING SEPARATE FINGER STICKS. REPORTER'S RESULTS WERE 201, 366 AND 157 MG/DL. REPORTER DID NOT HAVE ANY SYMPTOMS. ON FOLLOWUP, THE REPORTER STATED CHECKING THE CONFIRMATION DOT. REPORTER'S TECHNIQUE OF APPLYING BLOOD IS ACCURATE. REPORTER HAD CLEANED THE METER ONCE IN OVER A YEAR. THE REPORTER STATES DOING CONTROL TEST USING NEW SUPPLIES, AND HAD AN IN-RANGE RESULT. 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 64 YR Other