BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 1030271 · Received April 15, 2008

    Report

    Report Number
    2517506-2008-00035
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 15, 2008
    Report Date
    March 17, 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
    GA, 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 CCTIN TESTPAK CONTAINS THE FOLLOWING INFORMATION: "PATIENT 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 PATIENT 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 1.74 NG/ML WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE ORIGINAL SAMPLE WAS RETESTED ON ALTERNATE METHODOLOGY AND A RESULT OF 0.00 NG/ML WAS OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED AN 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 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 238021002

    Patients

    Seq Age Sex Outcome Treatment
    1