BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 2061342 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01209
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODULE HAD FAILED CALIBRATION AND THE CUSTOMER WAS INSTRUCTED TO DO CUP MAINTENANCE AND REPLACE THE ELECTRODE. THE MODULE SUCCESSFULLY CALIBRATED AND QC WAS WITHIN ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND NOTICED THE STIRRER MOTOR MAKING A GRINDING SOUND. THE FSE REPLACED THE STIRRER MOTOR, INSPECTED THE CUP, PERFORMED SAMPLE PROBE TO CUP ALIGNMENTS, CALIBRATED CUP, AND RAN QC. HARDWARE MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, A CLEAR ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT SYNCHRON CX9 ALX ANALYZER GENERATED SEVERAL ERRONEOUSLY HIGH BUN PATIENT RESULTS. THE CUSTOMER ONLY PROVIDED ONE EXAMPLE OF THE RESULT THAT WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED. THE RESULT WAS AMENDED. THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. CX9 ALX

    Patients

    Seq Age Sex Outcome Treatment
    1