BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3914702 · Received July 3, 2014

    Report

    Report Number
    2432235-2014-00407
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) WAS CONTACTED BY THE CUSTOMER. THE HSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE NON-SIEMENS LABORATORY INFORMATION SYSTEM WAS PROCESSING INTERMEDIATE TEST FRAMES INCORRECTLY AND THAT THERE WAS NO INSTRUMENT MALFUNCTION DURING THE TIME OF THE EVENT. THE CAUSE OF THE LIS NOT PROCESSING RECORDS CORRECTLY WHEN THE LIS MESSAGE DISPLAYS TWO INTERMEDIATE TEST FRAMES IS DUE TO THE CUSTOMER'S NON-SIEMENS LABORATORY INFORMATION SYSTEM (LIS). THE HSC DETERMINED THAT THE ADVIA CENTAUR XP IS PERFORMING TO SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE LABORATORY INFORMATION SYSTEM (LIS) IS NOT PROCESSING RECORDS CORRECTLY WHEN THE LIS MESSAGE DISPLAYS TWO INTERMEDIATE TEST FRAMES ON AN ADVIA CENTAUR XP INSTRUMENT. THE LIS ADDED THE SEQUENCE NUMBER OF '2' TO A (B)(6) VIRUS (B)(6) TEST RECORD. THIS OCCURRED WITHIN THE RESULT FIELD, THEREFORE THE LIS ADDED A 2 TO THE RESULT VALUE WHEN IT PROCESSED THE (B)(6) PATIENT RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LIS NOT PROCESSING RECORDS CORRECTLY WHEN THE LIS MESSAGE DISPLAYS TWO INTERMEDIATE TEST FRAMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390739 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1