BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA

    MDR report key: 898547 · Received August 14, 2007

    Report

    Report Number
    2432235-2007-00032
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    July 20, 2007
    Report Date
    July 20, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES REQUESTED FROM CUSTOMER, BUT HAVE NOT BEEN RECEIVED YET. STILL AWAITING RECEIPT TO ALLOW FOR ANALYSIS. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS HAS ISSUED TWO CUSTOMER BULLETINS TO PROVIDE MORE INFORMATION AND INSTRUCTION TO CUSTOMERS REGARDING THIS TROPONIN ULTRA ISSUE. ADDITIONALLY, A RESOLUTION FOR THIS ISSUE HAS BEEN IDENTIFIED AND WILL BE AVAILABLE IN OCTOBER, 2007. PLEASE REFER TO THE TWO CUSTOMER BULLETINS ATTACHED TO THIS REPORT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER STATED, PATIENT WAS ADMITTED FROM ANOTHER HOSPITAL DUE TO ELEVATED TROPONIN ULTRA (CTNI) RESULTS ON AN ADVIA CENTAUR. PATIENT WAS DRAWN AT SITE WITH INITIAL RESULT OF CTNI 12.1 NG/ML WITH CKMB < 0.20 AND CK = 60. CUSTOMER STATED, THAT QC WAS ALL IN RANGE AND SAMPLE HEPARINIZED PLASMA ALIQUOT. CUSTOMER STATED, PATIENT WAS RE-DRAWN, RUN AND RESULT OF CTNI WAS 9.48 NG/ML. ALL RESULTS WERE RELEASED AND PATIENT UNDERWENT CARDIAC CATHETERIZATION THAT WAS DIAGNOSED AS NORMAL. CUSTOMER STATED THAT UPON REPEAT OF BOTH SAMPLES ON ANOTHER CENTAUR, RESULTS WERE 4.5 NG/ML AND 2.0 NG/ML RESPECTIVELY. CUSTOMER DILUTED SAMPLES AT 1:10 AND CALCULATED RESULTS WERE 0.18 AND 0.19 RESPECTIVELY. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA TROPONIN IMMUNOASSAY MMI SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 012

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other