BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 1994171 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00449
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) FOUND ALKALINE BUFFER EXIT PORT ON CO2 MEASURE ELECTRODE PARTIALLY OCCLUDED WITH RED MATERIAL. THE FSE REPLACED THE CO2 MEASURE ELECTRODE. THE FSE ALSO FOUND A LARGE AMOUNT OF PROTEIN BUILDUP AT AND PAST THE ACID MIXING CHAMBER. THE FSE CLEANED FLOWCELL AND VERIFIED THE INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY LOW CHLORIDE (CL) RESULT GENERATED BY SYNCHRON CX DELTA CLINICAL SYSTEM. THE RESULT WAS REPORTED OF THE LABORATORY. WHEN THE CUSTOMER REPEATED THE SAMPLE DUE TO OTHER SUPPRESSED RESULT, THE DISCREPANCY IN RESULTS WAS NOTED. THE SAMPLE WAS RETESTED AGAIN AND THE RESULT MATCHED THE 2ND RUN. THE RESULT WAS AMENDED. PER THE CUSTOMER ON (B)(6) 2011, PATIENT TREATMENT WAS NEITHER INITIATED NOR WITHHELD BASED UPON THE ERRONEOUS RESULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER, INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1