BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX3 DELTA CLINICAL SYSTEM

    MDR report key: 2001059 · Received February 24, 2011

    Report

    Report Number
    2050012-2011-00526
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K942676
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE EXAMINED THE FLOWCELL FOR OBSTRUCTIONS AND FOUND NONE. THE FSE ALSO REPLACED THE NA REFERENCE ELECTRODE. AS OF (B)(6) 2011 THERE HAVE BEEN NO FURTHER CALLS REGARDING ISE ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSE HIGH SODIUM (NA) AND POTASSIUM (K) RESULTS ON ONE PATIENT SAMPLE GENERATED BY THE SYNCHRON CX3 DELTA TOTAL PROTEIN ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED RESULTING IN LOWER RESULTS, WHICH WERE REPORTED OUT. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX3 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. CX3 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1