BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 2252635 · Received September 18, 2011

    Report

    Report Number
    2432235-2011-00133
    Event Type
    Malfunction
    Date Received
    September 18, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER(FSE) WAS NOT DISPATCHED TO THE CUSTOMER SITE AND THE CUSTOMER LAB MANAGER REPORTED THAT THE ADVIA CENTAUR COLOR CODING SYSTEM WAS VISIBLE ON THE ACID/ BASE DRAWER. THE CUSTOMER REPORTED THAT THEY REMOVED THE ACID BOTTLE FROM THE WASH 1 POSITION. THE CUSTOMER THEN REPORTED TO HAVE EMPTIED THE WASH 1 RESERVOIR AND PRIMED A FULL BOTTLE OF WASH 1 THROUGH THE WASH 1 LINE. THE CUSTOMER REPORTED TO HAVE RECALIBRATED THE ASSAYS THAT WERE CALIBRATED DURING THE TIME THE ACID BOTTLE WAS IN THE WASH 1 POSITION AND PERFORMED QC, WHICH WAS REPORTED WITH IN ACCEPTABLE RANGE. THIS INCIDENT WAS CAUSED BY USER ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD ACCIDENTALLY PLACED THE ACID BOTTLE IN THE SYSTEM WASH 1 BOTTLE LOCATION. DISCORDANT ADVIA CENTAUR TROPONIN-I (TNI) RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE HEALTH CARE PROVIDERS. THE SAMPLES WERE RETESTED AND THE CORRECTED REPORTS WERE ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1