BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2427620 · Received January 25, 2012

    Report

    Report Number
    2050012-2012-00198
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS FLUID UNDER REAGENT PROBE B OF THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20). CUSTOMER REPORTED THAT THE LX 20 DISPLAYED CARTRIDGE CHEMISTRY (CC) SYRINGE MOTION ERRORS AND CUVETTE NOT DRY BEFORE REAGENT INJECT ERRORS. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND LOW REAGENT LEVEL IN ALL CUP MODULES AND OVERFLOWS IN THE ELECTROLYTE INJECTION CUP. THE FSE REPLACED THE SMART MODULE. THE FSE PERFORMED MODULAR CHEMISTRY PROBE ALIGNMENTS. THE FSE PERFORMED CALIBRATION AND QUALITY CONTROL AND DID NOT NOTICE ANY ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1