BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER

    MDR report key: 1914676 · Received December 3, 2010

    Report

    Report Number
    2050012-2010-01506
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K188495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PERFORMANCE AT THE TIME OF THE EVENT IS UNKNOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED, DECONTAMINATED THE SYSTEM, AND REPLACED SOME PARTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING COMPLAINTS OF SEVERAL LOW SODIUM (NA) RESULTS BEING GENERATED BY THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER, WHICH WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT THEY ROUTINELY RUN ANY SAMPLE THAT GIVES A NA RESULT LESS THAN 134 MMOL/L. OF THOSE SAMPLES THAT WERE RERUN THEY GENERALLY REPEAT 5-10MMOL/L HIGHER. AN EXAMPLE WAS PROVIDED OF A 131 MMOL/L NA REPEATING AT 140MMOL/L. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT. THE PHYSICIANS QUESTION THE RESULTS AND HAD THEM REPEATED PRIOR TO ADJUSTING TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1