BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 4131016 · Received October 1, 2014

    Report

    Report Number
    2050012-2014-00449
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. CTS INSTRUCTED THE CUSTOMER TO REPLACE THE K (POTASSIUM) ELECTRODE AND RECALIBRATE THE INSTRUMENT. UPON COMPLETION OF REPLACING THE K ELECTRODE, CALIBRATION WAS SUCCESSFUL AND QC (QUALITY CONTROL) PASSED WITHIN SPECIFICATION. THE ISSUE WAS RESOLVED AND A FIELD SERVICE ENGINEER WAS NOT DISPATCHED OR REQUESTED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW K (POTASSIUM) RESULTS FOR TWO PATIENTS INVOLVING THE UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE CUSTOMER REPEATED THE SAMPLES ON THE SAME DXC (AFTER TROUBLESHOOTING) AND OBTAINED HIGHER K RESULTS. ONE OF THE TWO PATIENT SAMPLES WAS REPEATED ON AN ALTERNATE METHODOLOGY IN ADDITION TO THE DXC AND BOTH RESULTS MATCHED. THE ERRONEOUSLY LOW K RESULTS WERE REPORTED OUT OF THE LABORATORY AND LATER AMENDED. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER STATED THE K ELECTRODE STILL HAD 25 (TWENTY FIVE) MORE DAYS BEFORE THE REQUIRED MAINTENANCE OF REPLACING THE K ELECTRODE WAS DUE. A REVIEW IN THE REMOTE MANAGEMENT SYSTEM REVEALED QC (QUALITY CONTROL) RECOVERIES WERE ON THE LOW END OF THE 2SD (2 STANDARD DEVIATION) ASSIGNED TARGET MEAN VALUE ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613053 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1