BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 2942697 · Received February 4, 2013

    Report

    Report Number
    2432235-2012-00272
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    September 13, 2011
    Report Date
    August 8, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    2432235-08/16/2012-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. THE FSE CHECKED FOR BLEACH CONTAMINATION AT EACH FLUID LINE AND CONFIRMED BLEACH RESIDUAL AT THE RESUSPENSION PORT. THE FSE TESTED THE 3 WAY VALVES AND REPLACED THE WASH MANIFOLD, WASH TUBING, 3-WAY AND 2-WAY VALVES. SIEMENS INFORMED THE CUSTOMER TO PRIME THE RESUSPENSION PORT BEFORE RUNNING QC. A FIELD CORRECTION WAS IMPLEMENTED. NO FURTHER EVALUATION OF THE DEVICE IS NECESSARY. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. NOTE: (B)(4). SIEMENS DID NOT SEE THIS MDR POSTED ON THE FDA WEBSITE (MAUDE) AND IS RESENDING THIS MDR.

    Description of Event or Problem · 1

    AFTER A DAILY CLEANING PROCEDURE (DCP), THE CUSTOMER STATED CA 19-9A QC RESULTS WERE LOW. THE CUSTOMER HAS BEEN PRIMING EACH FLUID LINE PRIOR TO RUNNING QC AND SAMPLES. BASED ON THE INFORMATION PROVIDED THERE WERE NO INCORRECT PATIENT RESULTS ASSOCIATED WITH THIS COMPLAINT. SIEMENS PROVIDED A TEMPORARY WORKAROUND TO THE CUSTOMER AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46028 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1