BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 1844918 · Received September 20, 2010

    Report

    Report Number
    1219913-2010-00112
    Event Type
    Other
    Date Received
    September 20, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 2, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 045; ADDITIONAL EXPIRATION DATE: 02/28/2011. A SIEMENS FIELD APPLICATION SPECIALIST (FAS) WAS SENT TO THE CUSTOMER SITE. THE FAS TESTED THE SAMPLE ON TWO DIFFERENT LOTS OF TROPONIN ULTRA ON BOTH THE ADVIA CENTAUR CP AND THE ADVIA CENTAUR XP. THE RESULTS WERE POSITIVE. THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BASED ON ALL THE INFORMATION PROVIDED BY THE CUSTOMER, THIS SUGGESTS HETEROPHILIC INTERFERENCE ON THIS PATIENT SAMPLE. THE IFU STATES IN THE LIMITATIONS SECTION: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. SAMPLES FROM PATIENTS RECEIVING PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR THERAPY OR DIAGNOSIS MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SAMPLES MAY SHOW EITHER FALSELY ELEVATED OR FALSELY DEPRESSED VALUES WHEN TESTED WITH THIS METHOD."

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE OBTAINED FOR A PT'S SAMPLES. THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL WHEN THERE WAS NO CHANGE OR PROGRESS ON THE TROPONIN ULTRA RESULTS WITH TREATMENT. AT THE OTHER HOSPITAL, THE PT SAMPLE WAS TESTED USING THE ARCHITECT METHOD AND THE RESULT WAS NEGATIVE. THE PHYSICIAN AT THE FIRST HOSPITAL PRESCRIBED IMDUR, SIGMART, ASPIRIN AND PERFORMED PERCUTANEOUS CORONARY INTERVENTION (PCI). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 043

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ASPIRIN| ENOXAPARIN| HEPARIN| SIGMART| IMDUR| THIOTACID| MGO| NEOMYRL| CELEBREX| VALIUM| MACPERAN| APITRROL| INDEROL