BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2274823 · Received October 4, 2011

    Report

    Report Number
    2432235-2011-00141
    Event Type
    Malfunction
    Date Received
    October 4, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATING THE INSTRUMENT, THE FSE CLEANED THE BARCODE READER TO REMOVE SERUM, PROACTIVELY BLACKENED WORN AREAS OF THE READER'S BACKSTOP, RE-CALIBRATED THE BARCODE THRESHOLD, AND RAN BARCODE TUBES TO CHECK THE READER. THE ACTUAL CAUSE COULD NOT BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN AS TO WHAT CAUSED THE BARCODE READER TO MISREAD THE AFP SAMPLE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    THE SYSTEM SAMPLE BARCODE READER ON AN ADVIA CENTAUR XP ANALYZER MISREAD ONE (1) AFP PATIENT SAMPLE BARCODE. THE LABORATORY NOTICED THE SAMPLE ID MISMATCH ERROR DURING MANUAL REVIEW OF THE SAMPLE IDS AND RESULTS. THE MISMATCHED AFP RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED, AND THE CORRECT RESULT WAS REPORTED OUT. THERE WERE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SYSTEM SAMPLE BARCODE READER HAVING MISREAD THE AFP SAMPLE BARCODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1