BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2840814 · Received November 20, 2012

    Report

    Report Number
    2432235-2012-00414
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    2432235-11/14/2012-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND FOUND A SENSOR 2 ERROR AND INTERMITTENT LID SENSOR ACTIVATION. ADDITIONALLY BLEACH WAS FOUND IN THE WASH 1 BOTTLE AND RESERVOIR. THE FSE RESEATED ALL WIRING CONNECTIONS AND DECONTAMINATED THE WASH 1 LINES. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED. AN URGENT MEDICAL DEVICE CORRECTION (UMDC), UMDC (B)(4) - "ADVIA CENTAUR / ADVIA CENTAUR XP SYSTEM MISINTERPRETS WASH 1 FLUID SIGNALS", WAS SENT TO CUSTOMERS IN (B)(4) 2012.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED THAT ON AN ADVIA CENTAUR XP INSTRUMENT THE SYSTEM FLAGGED WASH 1 REAGENT AS LOW WHILE THE REAGENT BOTTLE WAS FULL BUT THE SYSTEM HAD DRAINED THE RESERVOIR. AT THIS TIME ABOUT 10 (B)(6) SURFACE ANTIGEN ((B)(6)) RESULTS WERE OBTAINED. ALL OF THEM WERE (B)(6). THESE RESULTS WERE NOT RELEASED BY THE LABORATORY. THE CUSTOMER SAVED THE SAMPLES AND THEY WERE RERUN AFTER SERVICE WITH NO DISCORDANT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INJURY OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY OF (B)(6) 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