BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 7235585 · Received February 2, 2018

    Report

    Report Number
    2432235-2018-00037
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 5, 2018
    Report Date
    February 1, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414573564
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. AFTER INSPECTING THE INSTRUMENT, THE CSE PERFORMED A TOTAL SERVICE MAINTENANCE WHEN HE NOTICED WASH 1 WAS FOAMING DURING THE DISPENSE TEST. THE CSE CLEANED THE BUBBLE OF LIQUID BUILT UP IN THE WASH DRAIN (WD) NOZZLES WITH A KEM WIPE. THE CSE REPLACED BOTH WASH AND WATER VALVES AS THEY POTENTIALLY CONTRIBUTED TO THE LIQUID BUILD UP. THE CSE CLEANED THE INTERIOR OF CUVETTE BIN AND DEIONIZING (DI) FAN AS PRECAUTIONARY MEASURE AGAINST ELECTROSTATIC CHARGE. THE CSE REPLACED A BROKEN STRAW, WHICH OCCURRED DURING THE REMOVAL OF THE ACID RESERVOIR. THEN, THE CSE PRIMED THE SYSTEM WITH DI WATER. THE INSTRUMENT WAS FUNCTIONING PROPERLY. THE CSE RETURNED TO THE CUSTOMER'S SITE DUE TO ACID PUMP FAILURE. THE CSE REPLACED ALL BULK FLUID RESERVOIR MANIFOLDS AND THE VALVE 70 (V70) AS IT WAS CLOSED DURING PRIMING. THE CSE PRIMED THE ACID AND BASE FLUIDS WITH DI WATER AND FRESH FLUIDS. THE CSE REPLACED THE WASH MANIFOLD WASH BLOCKS. THEN, THE CSE RAN QUALITY CONTROL (QC), RESULTING WITHIN SPECIFICATION. THE CAUSE OF THE DISCORDANT, LOW IPTH RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS INSTRUMENT IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER OBTAINED A DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE (IPTH) RESULT ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE CUSTOMER OBSERVED SIGNAL ERRORS ON THE INSTRUMENT AND REFRIGERATED THE SAMPLE. ON (B)(6) 2018, THE SAME SAMPLE WAS RERUN, IN DUPLICATE, ON THE SAME INSTRUMENT, POST SERVICE, RESULTING HIGHER. THE FIRST REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81521 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP 00630414573564

    Patients

    Seq Age Sex Outcome Treatment
    1