BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON

    MDR report key: 48001 · Received September 16, 1996

    Report

    Report Number
    2050012-1996-00007
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Date of Event
    August 24, 1996
    Report Date
    September 16, 1996
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    WHEN RUNNING A SAMPLE ON THE DEVICE, IN THE MANUAL ORDAC (OUT OF RANGE DETECTION AND CORRECTION) MODE, A GLUCOSE RESULT WAS OBTAINED THAT WAS 1/2 OF THE ACTUAL VALUE. THE CUSTOMER REPORT WAS CONFIRMED AND IT WAS NOTED THAT A BUN RESULT COULD ALSO BE AFFECTED, HOWEVER A SPECIFIC SEQUENCE OF SYSTEM EVENTS AND TEST REQUESTS WERE REQUIRED TO SEE THIS RESULT ANOMALY IN THE GLUCOSE AND/OR BUN RESULT. NO INJURIES HAVE BEEN ATTRIBUTED TO THIS EVENT.

    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 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 *