BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 275756 · Received April 27, 2000

    Report

    Report Number
    2939301-2000-00326
    Event Type
    Malfunction
    Date Received
    April 27, 2000
    Report Date
    March 30, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER DID METER TO LAB COMPARISON TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGER STICKS. REPORTER'S METER TEST (CAPILLARY) WAS 120MG/DL, AND THE VENOUS LAB TEST RESULT WAS 170MG/DL. REPORTER DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS IN RANGE, 128 (101-151). 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 73 YR Other