BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3100547 · Received May 8, 2013

    Report

    Report Number
    2432235-2013-00169
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MZP
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE PROACTIVELY REPLACED THE ASPIRATE PINCH VALVES. THE FSE THEN RAN TWENTY REPLICATES OF A PATIENT SAMPLE WITHOUT ANY DISCORDANT RESULTS. PRIOR TO SERVICE, THE SAMPLE THAT HAD RESULTED (B)(6), AND THE SECOND TUBE FROM THE PATIENT HAD CONSISTENTLY RESULTED (B)(6). THE CAUSE OF THE DISCORDANT, (B)(6) RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, (B)(6) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) BECAUSE THEY DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT AND THE PATIENT'S PRIOR RESULT. THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED (B)(6). THE SAMPLE WAS ALSO RERUN ON THE SAME INSTRUMENT FIVE TIMES THE FOLLOWING DAY, AND FOUR REPLICATES RESULTED (B)(6). A DIFFERENT SAMPLE TUBE FROM THE SAME PATIENT WAS THEN TESTED FIVE TIMES, AND ALL REPLICATES RESULTED AS (B)(6). THE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202088 ADVIA CENTAUR IMMUNOASSAY ANALYZER MZP SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1