BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2072332 · Received April 28, 2011

    Report

    Report Number
    2050012-2011-01259
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) HAD CUSTOMER STOP SYSTEM FUNCTION AND PLACE PAPER TOWELS IN COMPARTMENT. CUSTOMER WAS UNABLE TO LOCATE SOURCE OF THE LEAK. CTS RECOMMENDED CUSTOMER TO REPLACE REAGENT SYRINGE AND PRIME REAGENT SUB SYSTEM. CUSTOMER WAS STILL GETTING CUVETTE NOT DRY FLAG. CTS ALSO RECOMMENDED REPLACING WASH TOWER WIPER AND DOING SYSTEM POWER DOWN REBOOT WHICH DID NOT RESOLVE THE PROBLEM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(6) 2011 AND REPLACED THE HAMILTON AND T-VALVES TO STOP REAGENT PROBE LEAKING. FSE ALSO REPLACED LEVEL SENSE BEAD DUE TO WET CUVETTE UPON DISPENSING REAGENT AND REPLACED THE CUVETTE WASH TOWER MANIFOLD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT LIQUID WAS DRIPPING ONTO COVER FROM REAGENT PROBES AND GETTING CC CUVETTE NOT DRY FLAGS. NO INJURY WAS REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX®I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1