BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1918169 · Received December 2, 2010

    Report

    Report Number
    2432235-2010-00181
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 3, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. UPON INITIAL INSPECTION OF THE INSTRUMENT THE FSE FOUND PARTICLES COVERING THE TOP AS WELL AS INSIDE THE INSTRUMENT. THE FACILITY HAD CHANGED THE CEILING TILES AND IT APPEARED THAT DUST HAD ENTERED THE INSTRUMENT. THE FSE CLEANED THE INSTRUMENT AND CHECKED THE ASPIRATE PROBES AND FOUND THE INSTRUMENT TO BE OPERATIONAL. BASED ON THE INFO PROVIDED BY THE CUSTOMER AND EVALUATION OF THE INSTRUMENT IT IS UNK WHAT CAUSED THE DISCORDANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP TUP, T4, TSH, FT4, TESTOSTERONE (TESTO), FT3, LH, PROLACTIN (PRO) AND FOLATE (FOL) RESULTS WERE OBTAINED AND REPORTED TO THE PHYSICIAN(S). A PHYSICIAN QUESTIONED SOME OF THE REPORTED THYROID RESULTS. SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER CDZ SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP NA

    Patients

    Seq Age Sex Outcome Treatment
    1