BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 300466 · Received October 10, 2000

    Report

    Report Number
    2939301-2000-00816
    Event Type
    Malfunction
    Date Received
    October 10, 2000
    Report Date
    September 10, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THEY DID BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TESTS, USING DIFFERENT FINGERSTICKS. THE RESULTS WERE 173, 225 AND 190 MG/DL. THE REPORTER DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST WAS IN RANGE, 115 (91-130). 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 63 YR Other