BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3033557 · Received April 3, 2013

    Report

    Report Number
    2432235-2013-00119
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER INFORMED THE TSC SPECIALIST THAT SHE HAD PUT A BOTTLE OF BASE SOLUTION IN THE WASH 1 BOTTLE POSITION. PATIENT SAMPLES BEING TESTED FOR ESTRADIOL WERE RUNNING DURING THE TIME THIS OCCURRED. THE TSC SPECIALIST ADVISED THE CUSTOMER TO DISCARD THE CONTENTS OF THE RESERVOIR, REPLACE THE BASE SOLUTION WITH WASH 1 SOLUTION, AND PRIME THE FLUID BOTTLE AND FLUID LINES. THE CUSTOMER DID SO AND THEN RAN QUALITY CONTROLS, WHICH WERE WITHIN RANGE. ALL PATIENT SAMPLES WERE THEN RERUN, AND IT WAS DISCOVERED THAT THE RERUN RESULTS FOR TWO PATIENT SAMPLES DID NOT MATCH THE INITIAL RESULTS. THE CAUSE OF THE DISCORDANT ESTRADIOL RESULTS WAS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ESTRADIOL RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT, AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136467 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1