BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR

    MDR report key: 2022390 · Received March 17, 2011

    Report

    Report Number
    2432235-2011-00039
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT. AFTER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE FOUND THE ASPIRATION PROBE FOUR PINCH VALVE STICKING OPEN AND IT WAS REPLACED. THE FSE THEN RAN CONTROLS AND A SMALL PRECISION STUDY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR THCG RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULT (SINCE IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY) AND THE LABORATORY REPEATED THE SAME SAMPLE IN DUPLICATE ON A SECOND INSTRUMENT. THE LABORATORY THEN REPEATED THE SAMPLE A SECOND TIME ON BOTH SYSTEMS TO CONFIRM. CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT THCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1