BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3 DELTA

    MDR report key: 2515563 · Received April 3, 2012

    Report

    Report Number
    2050012-2012-00844
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    March 16, 2012
    Report Date
    March 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJF
    PMA / PMN Number
    K942676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE IS ATTRIBUTED TO THE CREATININE CUP NOT DRAINING PROPERLY. THE ISSUE WAS RESOLVED WITH THE REPAIRS PERFORMED BY THE FIELD SERVICE ENGINEER. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE SYNCHRON CX3 DELTA CREATININE MODULE ERRONEOUSLY GENERATED ONE HIGH PATIENT RESULT. THE PATIENT WAS FIRST DRAWN AT 5 A.M., AND THEN AGAIN AT 8 A.M., AFTER WHICH THE DISCREPANT RESULT WAS DISCOVERED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE CREATININE CUP WAS NOT DRAINING PROPERLY. THE FSE REPLACED THE REACTION CUP, THE PREHEATER, AND THE STIR MOTOR TO ADDRESS THE ISSUE. THE FSE THEN VERIFIED PROPER INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED.

    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. CX3 DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1