BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 1890382 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01192
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND DID NOT SEE ANY LEAK FROM THE CRE OR TP CUP. FSE INSPECTED THE MODULAR CHEMISTRY (MC) WASTE MANIFOLD AND VACUUM CANISTER AND FOUND CLOGGED FITTINGS AND THE CANISTER WAS DIRTY. FSE CLEANED THE CLOGGED LINES AND CANISTER AND VERIFIED SYSTEM OPERATION FOLLOWING CALIBRATION AND QC RUN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING BOTH THE CREATININE (CRE) AND TOTAL PROTEIN (TP) CUPS WERE OVER FILLING AND REAGENT WAS LEAKING ON THE FLOOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1