BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON

    MDR report key: 52964 · Received November 20, 1996

    Report

    Report Number
    2050012-1996-00008
    Event Type
    Malfunction
    Date Received
    November 20, 1996
    Date of Event
    October 22, 1996
    Report Date
    November 7, 1996
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN RUNNING A CHEMISTRY PANEL ON PT SAMPLES USING THE DEVICE, TWO GLUCOSE RESULTS WERE ELEVATED. CUSTOMER RE-RAN THE SAMPLES AND RESULTS WERE PRODUCED THAT WERE APPROX 1/2 OF THE ORIGINAL VALUE. ALL OTHER ANALYTES MEASURED IN THE REPEATED CHEMISTRY PANEL WERE THE SAME OR NEAR THE ORIGINAL RESULTS. SPURIOUS INSTRUMENT CODES WERE SEEN ON THE REPORTS OF THE ELEVATED RESULTS. NO INJURY OR TREATMENT WAS ATTRIBUTED TO THE ELEVATED GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CLINICAL CHEMISTRY ANALYZER S/W VER. 4.0 + JJC BECKMAN INSTRUMENTS, INC. CX7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other