BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2427034 · Received January 25, 2012

    Report

    Report Number
    2050012-2012-00269
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    December 25, 2011
    Report Date
    December 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGJ
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED WITH THE HARDWARE REPAIRS PERFORMED BY THE FSE, INCLUDING THE REPLACEMENT OF THE DEFECTIVE TUBING. PLEASE NOTE THAT TWO ADDITIONAL MEDICAL DEVICE REPORTS WERE FILED BASED ON THE SAME SET OF EVENTS AS MEDWATCH #2050012-2012-00268 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)) AND MEDWATCH #2050012-2012-00270 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE SYNCHRON LXI 725 CLINICAL SYSTEM GENERATED FALSELY HIGH MAGNESIUM RESULTS FOR ONE PATIENT SAMPLE. CUSTOMER STATED THAT THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE, CC SAMPLE WASH COLLAR, AND BOTH CC REAGENT WASH COLLARS. THE FSE THEN PERFORMED ALIGNMENTS WITHOUT FINDING ANY ERRORS. NEXT, THE FSE REPLACED THE DEFECTIVE TUBING AND THE VACUUM PROBE ON THE CUVETTE WASH ASSEMBLY. FINALLY, THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGJ BECKMAN COULTER, INC. LXI 725

    Patients

    Seq Age Sex Outcome Treatment
    1