BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 2900371 · Received January 7, 2013

    Report

    Report Number
    1219913-2013-00009
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNKNOWN. THE QC WAS ACCEPTABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE SAMPLE WAS PART OF A SERIAL DRAW AND THE RESULT WAS QUESTIONED BY THE OPERATOR. A NEW SAMPLE WAS DRAWN AND TESTED. THE RESULT WAS NEGATIVE. REPEAT TESTING WAS PERFORMED ON THE INITIAL POSITIVE SAMPLE AND THE RESULT WAS NEGATIVE. THE FINAL RESULT WAS REPORTED AS NEGATIVE. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6696 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 069

    Patients

    Seq Age Sex Outcome Treatment
    1