BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 275749 · Received April 28, 2000

    Report

    Report Number
    2939301-2000-00338
    Event Type
    Malfunction
    Date Received
    April 28, 2000
    Report Date
    March 31, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN MINUTES OF EACH OTHER, USING SEPARATE FINGER STICKS. RPTR'S RESULTS WERE 142, 197, AND 203 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. THE RPTR CHECKS THE CONFIRMATION DOT FOR ENOUGH BLOOD. A CONTROL SOLUTION TEST WAS IN RANGE. 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 70 YR Other