BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 6142812 · Received December 2, 2016

    Report

    Report Number
    2432235-2016-00744
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 8, 2016
    Report Date
    December 2, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED THAT THE SAMPLE IN QUESTION WAS A FLUID SAMPLE OF UNKNOWN ORIGIN AND NOT A SERUM CEA. CCC ADVISED THAT THE METHOD IS NOT VALIDATED FOR THIS USE. A SIEMENS REGIONAL SUPPORT CENTER (RSC) SPECIALIST OBTAINED REMOTE ACCESS TO THE INSTRUMENT AND DISCOVERED THAT THE RELATIVE LIGHT UNIT (RLU) RESULT ASPECT OVERWROTE THE DOSE IN CENTRALINK THUS '0' (DOSE) DISPLAYED AT ADVIA CENTAUR XP INSTRUMENT BUT '1336' (RLU) WAS DISPLAYED AT CENTRALINK. THE RSC SPECIALIST IDENTIFIED THE CAUSE WAS DUE TO A MISSING "RESULT SELECTOR" IN THE CENTRALINK SETTING FOR THE FLUID CEA METHOD. WHEN A "RESULT SELECTOR" IS NOT ASSIGNED, ALL OF TEST RESULT ASPECTS (DOSE, RLU, ETC) ARE RECEIVED BY CENTRALINK AND ONLY THE LAST ASPECT IS SAVED. THE RSC SPECIALIST CONCLUDED THAT THE ISSUE WAS DUE TO INCORRECT TEST SETUP BY THE CUSTOMER. THE CONFIGURATION HAS BEEN CORRECTED. THE CAUSE OF ERRONEOUS CEA RESULTS ON CENTRALINK WAS DUE TO A CONFIGURATION ISSUE. USING FLUID CEA IS OFF LABEL USE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ERRONEOUS, FLUID CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WERE TRANSMITTED TO THE CENTRALINK DATA MANAGEMENT SYSTEM. THE CEA RESULT DISPLAYED IN THE ADVIA CENTAUR XP INSTRUMENT WAS '0', HOWEVER, CENTRALINK DISPLAYED A RESULT OF 1336. THE CUSTOMER REPEATED THE SAMPLE UNDILUTED ON THE SAME INSTRUMENT, AND ANOTHER '0' RESULT WAS OBTAINED. THE CUSTOMER STATED THAT THE INITIAL RESULTS RECEIVED ON CENTRALINK, IN DUPLICATE RESULTED 1464 AND 1536. THE INITIAL RESULT DISPLAYED ON THE CENTRALINK WAS NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CEA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792301 CENTRALINK DATA MANAGEMENT SYSTEM DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1