BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL ANALYZER

    MDR report key: 1891542 · Received November 4, 2010

    Report

    Report Number
    2050012-2010-01194
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER BY ISOLATING THE ISSUE TO LOOSE TUBING TO THE SAMPLE PROBE. THE CUSTOMER CORRECTED THIS AND CLEANED THE SPILL ON THE INSTRUMENT. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING MOST OF THE CX4 SIDE CHEMISTRIES WERE PRODUCING SUPPRESSED RESULTS. THE CUSTOMER DETERMINED THAT THE REAGENT PROBE TUBING WAS LOOSE AND LEAKING AT THE PROBE. NO OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX9 ALX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1