BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3900970 · Received June 30, 2014

    Report

    Report Number
    2432235-2014-00398
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CHECKED THE SYSTEM TUBING FOR LEAKAGE AND CHECKED REAGENT PROBE 1, REAGENT PROBE 2, REAGENT PROBE 3 AND THE AUXILARY PROBE ALIGNMENTS. THE CSE REPLACED A TUBING SLEEVE AND PRIMED THE SYSTEM. THE CAUSE OF THE DISCORDANT TNIU RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CARDIAC TROPONIN I (TNIU) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ONCE WITH THE EXCEPTION OF TWO PATIENT SAMPLES WHICH WERE REPEATED THREE TIMES. THE LAST REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT TNIU RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380471 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1