BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3951413 · Received July 22, 2014

    Report

    Report Number
    2432235-2014-00478
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    OBF
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND ADJUSTED THE SAMPLE PROBE INSIDE THE REACTION CUVETTE. THE CAUSE OF THE DISCORDANT (B)(6) RESULT IS UNKNOWN. THE CSE PERFORMED AN INSTRUMENT CHECK AND SUCCESSFULLY RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, (B)(6) ANTIBODY TO (B)(6) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED TWICE ON AN ALTERNATE SYSTEM, RESULTING (B)(6). THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428466 ADVIA CENTAUR IMMUNOASSAY ANALYZER OBF SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1