BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®20 PRO SYSTEM

    MDR report key: 3081851 · Received April 29, 2013

    Report

    Report Number
    2050012-2013-00287
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED TROUBLESHOOTING WITH THE ASSISTANCE OF A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SPECIALIST) OVER THE PHONE AND DISCOVERED LEAKS FROM REAGENT PROBES A/B. THE CUSTOMER REPLACED REAGENT PROBES A/B VALVE AND THE REAGENT SYRINGE TO RESOLVE THE ISSUE. A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED FOR THIS EVENT. FAILURE MODE IS UNKNOWN AS MULTIPLE PARTS WERE REPLACED BY THE CUSTOMER TO RESOLVE THE LEAK. (B)(4). ISSUE WAS RESOLVED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING "CC (CARTRIDGE CHEMISTRY) SAMPLE CUVETTE NO FLUID DETECTED" ERROR MESSAGES INVOLVING THE SYNCHRON LX 20 PRO SYSTEM. THE CTS (CUSTOMER TECHNICAL SPECIALIST) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE AND THE CUSTOMER FOUND FLUID ON THE REACTION CAROUSEL COVER AND THE REAGENT PROBE DRIP TRAY. THE CUSTOMER REMOVED THE REAGENT PACKS AND STATED THAT THEY WERE WET. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CTS ADVISED THE CUSTOMER TO RETEST SAMPLES WHICH WERE PROCESSED ON THE INSTRUMENT PRIOR TO DISCOVERING THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GLASSES AND LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. BECKMAN COULTER REVIEWED THE PROVIDED PATIENT RESULTS DATA AND ALL CC CHEMISTRIES RESULTS WERE DETERMINED TO BE WITHIN BECKMAN COULTER'S ESTABLISHED PRECISION CLAIMS. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) RESULTS BEFORE AND AFTER THE EVENT WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184948 SYNCHRON LX®20 PRO SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1