BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2711954 · Received August 23, 2012

    Report

    Report Number
    2432235-2012-00260
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE ERROR TO BE RELATED TO CUSTOMER "MIS-POSITIONING" OF THE BARCODES. THE SYSTEM "SKIPPED" THE FIRST BARCODE THEN ASSIGNED THE BARCODE IN POSITION B TO POSITION A AND SO ON. THE BARCODES THEMSELVES WERE NOT MIS-READ. THE FSE CALIBRATED THE BARCODE READER VERIFIED THE RACK LOADER, LOADED RACKS AND VERIFIED THE PERFORMANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR THYROID STIMULATING HORMONE (TSH) WERE OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT DUE TO MISIDENTIFICATION OF SAMPLE BARCODES. THE RESULTS WERE REPORTED OUT. THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND CORRECTED REPORTS WERE SENT TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1