BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 4161976 · Received October 10, 2014

    Report

    Report Number
    2432235-2014-00588
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT INSPECTION. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA AND TROUBLESHOOTING TROPONIN IMPRECISION, THE CSE PERFORMED A TOTAL SERVICE CALL AND PREVENTATIVE MAINTENANCE. THE CSE OBSERVED AND RESOLVED A REAGENT PROBE LEAK BY TIGHTENING THE SCREW ON THE SYRINGE VALVE ASSEMBLY. THE ACID PUMP, ASPIRATE PROBE WASH PUMP, IONIZER, REAGENT SYRINGE, POSITIVE DISPLACEMENT PUMP (PDP), SAMPLE SYRINGE, REAGENT PROBE ASSEMBLY, LUMINOMETER, BUBBLE DETECTOR, VALVE BANK ASSEMBLY, WASH 1 PUMP, REAGENT DILUTOR, PROBE WASH PUMP, WASTE PUMP, GRAY PERI-PUMP WERE REPLACED AND THE SYSTEM DECONTAMINATED. THE CAUSE FOR THE DISCORDANT TROPONIN RESULT IS UNKNOWN. THERE WERE NO OTHER ASSAY RELATED ISSUES AT THE TIME OF THE INCIDENT, NO INSTRUMENT ERRORS OBSERVED IN THE SYSTEM EVENT LOG AND THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN QUALITY CONTROL RANGES. THE PATIENT SAMPLE WAS SLIGHTLY ICTERIC, HOWEVER, NO FIBRIN CLOTS WERE OBSERVED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN ULTRA (TNI UL) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE SAME SAMPLE WAS THEN REPEATED ON THE SAME INSTRUMENT AND ANOTHER ADVIA CENTAUR CP SYSTEM, RESULTING LOWER ON BOTH. A SECOND SAMPLE WAS DRAWN, TESTED AND REPEATED ON THE ORIGINAL INSTRUMENT AND THE OTHER ADVIA CENTAUR CP SYSTEM, RESULTING LOWER ON BOTH. THE LOWER RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644285 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1