BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 2100258 · Received May 24, 2011

    Report

    Report Number
    2517506-2011-00095
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 24, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K051650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS NON-SPECIFIC BINDING DUE TO HETEROPHILIC ANTIBODIES IN THE PATIENT SAMPLE. THE STRATUS(R) CS CTNI TESTPAK IFU STATES: "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. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE WITH EACH OF TWO REAGENT LOTS ON THE STRATUS(R) CS SYSTEM. THE ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT SYSTEM AND A NORMAL TROPONIN I RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS® CS STAT FLUOROMETRIC ANALYZER ACUTE CARE¿ TROPONIN I TESTPAK MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 230326002

    Patients

    Seq Age Sex Outcome Treatment
    1