BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 2820616 · Received November 6, 2012

    Report

    Report Number
    2432235-2012-00369
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL SUPPORT PERSONNEL DETERMINED THE CAUSE OF THE DISCORDANT BNP AND TESTOSTERONE RESULTS WAS A USER ERROR. THE CUSTOMER RAN THE INSTRUMENT WITH CLEANING SOLUTION INSTEAD OF WATER.

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL SUPPORT PERSONNEL DETERMINED THE CAUSE OF THE DISCORDANT BNP AND TESTOSTERONE RESULTS WAS A USER ERROR. THE CUSTOMER RAN THE INSTRUMENT WITH CLEANING SOLUTION INSTEAD OF WATER.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR B-TYPE NATRIURETIC PEPTIDE (BNP) AND TESTOSTERONE WERE OBTAINED ON AN ADVIA CENTAUR CP INSTRUMENT. NINE RESULTS WERE REPORTED OUT. THE CUSTOMER RAN THE SAME SAMPLES AGAIN AND CORRECTED RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BNP AND TESTOSTERONE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1