BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CHEMISTRY ANALYZER

    MDR report key: 1943102 · Received December 30, 2010

    Report

    Report Number
    2050012-2010-01788
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 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
    SF
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, LDLD QC RESULTS WERE LOW. THIS EVENT IS A REAGENT ISSUE AND IS CURRENTLY UNDER INVESTIGATION. SERVICE HAS NOT BEEN REQUESTED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY LOW RESULTS FOR LDL - CHOLESTEROL (LDLD) THAT WERE GENERATED BY THE SYNCHRON CX9 ALX CHEMISTRY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1