BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS

    MDR report key: 3961902 · Received July 28, 2014

    Report

    Report Number
    1217157-2014-00106
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JHX
    PMA / PMN Number
    K051650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL SUPPORT LAB (TSL) INVESTIGATED THE EVENT AND THEY INDICATED THAT THE PATIENT SAMPLE CONTAINED HETEROPHILIC ANTIBODIES. THE TROPONIN IFU CONTAINS THE FOLLOWING STATEMENTS IN THE LIMITATIONS OF PROCEDURE SECTION: "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 FROM ALL PATIENT SPECIMENS 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 AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TROPONIN RESULTS ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437927 STRATUS CS STRATUS CS JHX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR