BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2940426 · Received February 3, 2013

    Report

    Report Number
    2050012-2013-00058
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CARTRIDGE CHEMISTRY (CC) REAGENT SYRINGE DRIVE, THE CC REAGENT CRANE ASSEMBLY, AND THE CC SAMPLE SYRINGE. IT IS UNKNOWN OF WHICH REPLACEMENT HAD RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED C-REACTIVE PROTEIN (CRP) RESULTS FOR MULTIPLE PATIENTS INVOLVING A UNICEL DXC 600 SYNCHRON SYSTEM ON (B)(6) 2013. THE CUSTOMER PROVIDED INSTRUMENT PRINTOUTS FOR SEVEN PATIENT RESULTS WHICH WERE GENERATED ON (B)(6) 2013. TWO OF THE SEVEN PATIENT RESULTS PROVIDED BY THE CUSTOMER WERE OUTSIDE THE CRP TOTAL PRECISION OF 2 STANDARD DEVIATIONS (SD) SPECIFICATION. THIS REPORT IS FOR THE ERRONEOUS PATIENT RESULT WHICH WAS OBTAINED ON (B)(6). PLEASE SEE MEDWATCH #2050012-2013-00059 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON(B)(6). PATIENT RESULTS WHICH WERE OBTAINED ON (B)(6) WERE WITHIN THE CRP TOTAL PRECISION OF 2SD SPECIFICATION AND THEREFORE NO ERRONEOUS RESULTS WERE GENERATED. THE CUSTOMER OBTAINED A CRP RESULT OF 97.5 MG/L FOR A PATIENT ON (B)(6). THE SAMPLE WAS RERUN ON (B)(6) AND A RESULT OF 82.3 MG/L WAS OBTAINED. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY BUT THE CUSTOMER HAS NOT HEARD OF ANY IMPACT TO PATIENT CARE. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DETAILS OR ANY OTHER CHEMISTRY RESULTS FOR THE SAMPLES. THE CUSTOMER HAD INITIALLY CALLED BECKMAN COULTER ON (B)(6) 2013 TO REPORT AN ONGOING CRP IMPRECISION. AT THE TIME, THE CUSTOMER WAS UNAWARE IF ERRONEOUS PATIENT RESULTS HAD BEEN GENERATED OR REPORTED. THE CUSTOMER PROVIDED QUALITY CONTROL (QC) RESULTS FOR CRP FOR TWO DIFFERENT CONTROL LEVELS THAT SHOW ERRATIC IMPRECISION WHICH CAME BACK INTO THE 2SD RANGE UPON RERUN. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE CARTRIDGE CHEMISTRY (CC) REAGENT SYRINGE DRIVE, THE CC REAGENT CRANE ASSEMBLY, AND THE CC SAMPLE SYRINGE. FAILURE MODE IS HARDWARE RELATED AND SERVICE PERFORMED HAD RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45733 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1