BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 2854270 · Received December 3, 2012

    Report

    Report Number
    1219913-2012-00401
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE VISUAL CHECKS WERE GOOD. THE FSE OBSERVED THAT SOME OF THE TECHNICIANS TOP OFF THE WATER BOTTLE USING A FUNNEL AND THE FSE RECOMMENDED THAT THE WATER BOTTLE BE REMOVED FROM THE SYSTEM, EMPTIED AND REFILLED WITH FRESH WATER. THE FSE OBSERVED TECHNICIANS INVERTING THE SAMPLE TUBES AFTER SPINNING AND EMPHASIZED THAT TUBES SHOULD NOT BE INVERTED. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA WAS MOST LIKELY DUE TO SAMPLE COLLECTION AND HANDLING. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE INSTRUCTION FOR USE UNDER THE SPECIMEN COLLECTION AND HANDLING SECTION STATES THE FOLLOWING: "KEEP TUBES STOPPERED AND UPRIGHT AT ALL TIMES. BEFORE PLACING SAMPLES ON THE SYSTEM, ENSURE THAT SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER."

    Description of Event or Problem · 1

    A REPORTED FALSE POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULT WAS OBTAINED ON A SERIAL TROPONIN PATIENT SAMPLE DRAW AND WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE REPEAT NEGATIVE RESULT AND THE PREVIOUS NEGATIVE SAMPLE RESULTS. A CORRECTED REPORT WAS FORWARDED TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010067

    Patients

    Seq Age Sex Outcome Treatment
    1