BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 2863290 · Received December 10, 2012

    Report

    Report Number
    1219913-2012-00407
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 RESULTS IS UNKNOWN. THE ISSUE APPEARS TO BE SAMPLE PROCESSING. THE QUALITY CONTROL WAS ACCEPTABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULTS WERE OBTAINED FOR SAMPLES FROM TWO DIFFERENT PATIENTS. SUBSEQUENT SAMPLES FOR THE PATIENTS WERE TESTED AND THE RESULTS WERE NEGATIVE. REPEAT TESTING WAS PERFORMED ON THE INITIAL SAMPLES AND THE RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT 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
    1 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 066

    Patients

    Seq Age Sex Outcome Treatment
    1