BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1902503 · Received November 12, 2010

    Report

    Report Number
    2432235-2010-00162
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE FOUND THAT ASPIRATE PROBE 1 WAS INOPERATIVE, WHICH WAS THEN REPLACED. THE FSE RAN CALIBRATORS AND QC, THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND THE CAUSE OF THE DISCREPANT RESULT IS DUE TO THE ASPIRATE PROBE. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR XP TROPONIN RESULT WAS OBTAINED ON ONE PT SAMPLE. THE LABORATORY REPEATED THE SAMPLE SINCE THE QC WAS OUT OF RANGE. CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN REPORT OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1