BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1941357 · Received December 21, 2010

    Report

    Report Number
    2432235-2010-00194
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    NBC
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER THE GUIDANCE OF A SIEMENS TSE (TECHNICAL SERVICE ENGINEER), THE CUSTOMER PLACED THE WASH 1 BOTTLE IN THE CORRECT POSITION, PRIMED THE SYSTEM SEVERAL TIMES AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE CAUSE OF THE DISCORDANT BNP RESULTS WAS DUE TO THE BASE BOTTLE BEING PLACED IN THE WASH 1 POSITION.

    Description of Event or Problem · 1

    THREE (3) DISCORDANT LOW ADVIA CENTAUR BNP RESULTS WERE REPORTED ON PATIENT SAMPLES. THE OPERATOR HAD INCORRECTLY PLACED THE BASE BOTTLE IN THE WASH 1 POSITION AND THEN RAN THE SAMPLES. UPON REALIZING THE MISTAKE, THE SAMPLES WERE THEN RE-RUN ON AN ALTERNATE SYSTEM. THE REPEAT RESULTS MATCHED THE PRIOR PATIENT RESULTS AND WERE REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BNP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER NBC SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1