BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 6189128 · Received December 20, 2016

    Report

    Report Number
    2432235-2016-00782
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 20, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RUNS ESOTERIC TESTING ON AN ADVIA CENTAUR XP INSTRUMENT (CXP1) AND (B)(6) TESTING ON ANOTHER ADVIA CENTAUR XP INSTRUMENT (CXP2). AFTER THE INCIDENT OCCURRED THE CCC DISABLED IN CENTRALINK, (B)(6) TESTING ON THE CXP1 INSTRUMENT, TO STOP THE TEST FROM DOWNLOADING TO THAT INSTRUMENT. THE CUSTOMER RAN A TEST PATIENT, AND TESTING WAS PERFORMING AS EXPECTED. THE CAUSE OF THE (B)(6) RESULTS REPORTED OUT WAS DUE TO A USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED THEY ERRONEOUSLY VALIDATED AND REPORTED DISCORDANT RESULTS ON PATIENT SAMPLES TESTED FOR (B)(6). THE CUSTOMER ACCEPTED "X- NO RESULT" RESULTS IN THE CENTRALINK DATA MANAGEMENT SYSTEM, THEN MANUALLY VALIDATED THE RESULTS AND UPLOADED A VALUE OF "(B)(6)" IN THE LABORATORY INFORMATION SYSTEM. THE SAMPLES WERE REPEATED, AND CORRECTED RESULTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) VALUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839789 CENTRALINK DATA MANAGEMENT SYSTEM DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1