BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3082806 · Received April 29, 2013

    Report

    Report Number
    2432235-2013-00157
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, IT WAS DISCOVERED THAT A BOTTLE OF BASE REAGENT HAD BEEN PLACED IN THE WASH 1 REAGENT POSITION. THE FSE THEN CLEANED THE WASH 1 RESERVOIR AND DECONTAMINATED THE WASH 1 TUBING. IT WAS ALSO CONFIRMED THAT COLOR-CODED LABELS WERE PRESENT FOR THE ACID, BASE, AND WASH 1 REAGENT POSITIONS AND THAT THE OPERATOR WAS TRAINED ON PROPER FLUID POSITION ON THE ADVIA CENTAUR INSTRUMENT. THE CAUSE OF THE DISCORDANT TROPONIN RESULTS IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT TROPONIN RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT AFTER SERVICE AND RESULTED AS EXPECTED. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184963 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1