BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 280059 · Received May 25, 2000

    Report

    Report Number
    2939301-2000-00454
    Event Type
    Malfunction
    Date Received
    May 25, 2000
    Report Date
    April 28, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGER STICKS. THE RESULTS REPORTED WERE 193, 158, 149 AND 168 MG/DL. REPORTER DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST OF 127 WAS IN RANGE. NO HARM WAS ALLEGED. FOLLOW-UP ATTEMPTS TO CONTACT THE REPORTER FOR FURTHER 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