BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER

    MDR report key: 1895672 · Received November 10, 2010

    Report

    Report Number
    2050012-2010-01199
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K188495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) HAD THE CUSTOMER CHECK THE REAGENT SYRINGE AND PROBES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND INITIALLY CHECKED THE ALIGNMENTS FOR THE REAGENT PROBE AND MIXER. THE FSE THEN REPLACED THE VALVE FOR THE REAGENT PROBE. ALL CONTROLS WERE RUNNING TO SPECIFICATION, BUT SPLASHING STILL OCCURRING. SERVICE INSTALLED A NEW REAGENT PROBE AND SYRINGE. THE FSE ADJUSTED THE REAGENT PROBE DRIVE BELT TENSION, WHICH RESOLVED THE SPLASHING ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT A SPLASHING ON THE REAGENT TRAY WAS OBSERVED AFTER PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED ON THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER. NO OPERATOR EXPOSURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1