BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3 DELTA

    MDR report key: 2542017 · Received April 19, 2012

    Report

    Report Number
    2050012-2012-00994
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJF
    PMA / PMN Number
    K942676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE SYNCHRON CX3 DELTA GENERATED FALSELY HIGH CARBON DIOXIDE (CO2) RESULTS ON THREE PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, WHEN ANION GAPS FLAGGED THE SAMPLES, FIVE OF THE SAMPLES WERE RERUN AND THREE OF THE REPORTS WERE AMENDED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT CERTAIN HARDWARE PARTS REQUIRED REPLACEMENT AND MAINTENANCE. THE FSE REPLACED THE CO2 MEASURING ELECTRODE AND THE ELECTROLYTE INJECTION CUP (EIC) DRAIN VALVE. THE FSE ALSO CLEANED THE FLOWCELL. THE FSE THEN VERIFIED PROPER INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3 DELTA ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1