BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 802493 · Received January 5, 2007

    Report

    Report Number
    2432235-2007-00001
    Event Type
    Other
    Date Received
    January 5, 2007
    Date of Event
    December 1, 2006
    Report Date
    December 8, 2006
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, SWORDS CO.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR MEDICAL DEVICE REPORTING PURPOSES, THIS EVENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE PT CAME IN TO THE HOSP FOR AN EVALUATION. THE INITIAL BLOOD SAMPLE DRAWN (ZERO HOUR) GAVE A TROPONIN I RESULT OF 0.33 NG/NL. THE PT WAS ADMITTED AND UNDERWENT CARDIAC CATHETERIZATION AND ANGIOGRAM, BOTH OF WHICH WERE NEGATIVE. SERIAL DRAWS WERE ALSO TAKEN FROM THE PT AT 6 HRS AND 12 HRS, AND BOTH GAVE TROPONIN I RESULTS OF <0.1 NG/ML. THE INITIAL SAMPLE WAS LATER RE-TESTED ON 2 DIFFERENT CENTAUR INSTRUMENTS AND THE TROPONIN I RESULTS WERE <0.1 NG/ML IN BOTH CASES. A SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS FIELD ENGINEER EVALUATED THE INSTRUMENT AND FOUND NO EVIDENCE OF SYSTEM MALFUNCTION. QUALITY CONTROLS WERE ALSO RUN AND THEIR RESULTS WERE WITHIN SPECIFICATION. DISCUSSIONS WITH THE CUSTOMER INDICATE IMPROPER SAMPLE HANDLING AS THE POTENTIAL CAUSE FOR THE DISCREPANT RESULT. PROPER SAMPLE HANDLING INSTRUCTIONS AND RECOMMENDATIONS FROM THE SAMPLE TUBE SUPPLIER HAVE BEEN REVIEWED WITH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNO-ASSAY JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, SWORDS CO. ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other