BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEMS

    MDR report key: 2172247 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-02988
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN GOLD SERUM SEPARATOR TUBES. SAMPLE COLLECTION AND HANDLING ARE CLOSELY MONITORED. PER THE CUSTOMER, QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QA REVIEWED THE PROVIDED DATA AND NOTED THAT QC DOES SHIFT HIGHER APPROXIMATELY 3 MMOL/L UPON RECALIBRATION. THE CUSTOMER REPLACED THE NA ELECTRODE AND CLEANED THE ELECTROLYTE INJECTION CUP (EIC) PRIOR TO SERVICE ARRIVAL. A BEC FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND WAS UNABLE TO FIND ANY ISSUES. FSE VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS FOR 24 PATIENT SAMPLES GENERATED BY THE SYNCHRON CX9 ALX CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE, PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. WHEN THE SAMPLES FAILED DELTA CHECK, THE SAMPLES WERE REPEATED AFTER RECALIBRATION AND HIGHER RESULTS WERE OBTAINED AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEMS DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE. JGS BECKMAN COULTER INC. CX9 ALX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1