BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 9837665 · Received March 16, 2020

    Report

    Report Number
    2432235-2020-00235
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 16, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414573564
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND INFORMED THAT THE ADVIA CENTAUR XP INSTRUMENT MESSAGED THAT THE PACK ID: 12592 OBS (ONBOARD STABILITY) HAD EXPIRED. SIEMENS REVIEWED THE CANCER ATINGEN (CA 15-3) REAGENT LOT 043179 AND CONFIRMED THE EXPIRATION IS DUE ON 29-APRIL-2020. THE CUSTOMER STATED THAT THEY DID NOT KNOW THE EXPIRATION DATE AND USED THE PRESENT DATE (E.G., 25-FEBRUARY-2020) AS THE OBS. AFTER NOTICING THE ISSUE AND PERFORMING TROUBLESHOOTING, THE CUSTOMER USED THE CORRECT EXPIRATION DATE AND PERFORMED REPEAT TESTING TO OBTAIN THE CORRECT RESULTS. SIEMENS EVALUATED THE EVENT AND CONCLUDED THAT THE CUSTOMER'S HANDLING OF THE REAGENT WAS INAPPROPRIATE. THE USER HAD INCORRECTLY ENTERED THE EXPIRATION DATE, AND CAUSED THE RESULTS TO BE ZERO DUE TO EXPIRED OBS. THE CUSTOMER RESOLVED THE ISSUE AND THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT IS DUE TO A USE ERROR. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FIVE DISCORDANT, FALSELY DEPRESSED, CANCER ANTIGEN (CA 15-3) TEST RESULTS ON AN ADVIA CENTAUR XP INSTRUMENT. THE CUSTOMER INFORMS THAT DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES AND INSTRUMENT WERE USED TO PERFORM REPEAT TESTING. THE CUSTOMER INFORMS THAT CORRECT RESULTS WERE OBTAINED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 15-3 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298669 ADVIA CENTAUR XP ADVIA CENTAUR XP JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP 00630414573564

    Patients

    Seq Age Sex Outcome Treatment
    1