BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 4182075 · Received October 17, 2014

    Report

    Report Number
    2432235-2014-00599
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT INSPECTION. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE PERFORMED A TOTAL SERVICE CALL, REPAIRED REAGENT PROBE 3 VERTICAL MOVEMENT ERRORS, CALIBRATED ALL OF THE PROBES, AND CHECKED INSTRUMENT PRECISION. THE CUSTOMER'S QUALITY CONTROL LEVEL III RESULT WAS WITHIN ACCEPTABLE RANGES AT THE TIME OF THE EVENT, AND THERE WERE NO OTHER DISCORDANT HCG RESULTS OR SYSTEM ERRORS OBSERVED DURING INITIAL TESTING. THE CAUSE FOR THE FOUR FALSE NEGATIVE ADVIA CENTAUR XP HCG RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT AND CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TEST RESULTS. THE CUSTOMER REALIZED THEY HAD NOT RUN QUALITY CONTROL LEVELS I AND II WHEN INITIAL TESTING WAS PERFORMED AND APPROXIMATELY 200 PATIENT SAMPLES WERE REPEATED. OF THE PATIENT SAMPLES REPEATED, THE CUSTOMER DISCOVERED FOUR DISCORDANT RESULTS. THE SAMPLES WERE RUN ON THE SAME INSTRUMENT AND ANOTHER ADVIA CENTAUR XP INSTRUMENT, RESULTING POSITIVE ON BOTH. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660969 ADVIA CENTAUR XP CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1