BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 1052141 · Received May 16, 2008

    Report

    Report Number
    2517506-2008-00043
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    MMI
    PMA / PMN Number
    K051650
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS HETEROPHILIC ANTIBODY. THE IFU FOR STRATUS CS CCTNI TESTPAK CONTAINS THE FOLLOWING INFO: "PT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PT HISTORY SHOULD BE INTERPRETED WITH CAUTION." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT OF 1.25 NG/ML WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE ORIGINAL SAMPLE WAS RETESTED ON ALTERNATE METHODOLOGY AND A NEGATIVE RESULT WAS OBTAINED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS HETEROPHILIC ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS CS STAT FLUOROMETRIC ANALYZER ACUTE CARE TROPONIN I TEST PAK MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC NA 238070002

    Patients

    Seq Age Sex Outcome Treatment
    1