BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS

    MDR report key: 4090137 · Received September 15, 2014

    Report

    Report Number
    1217157-2014-00116
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JHX
    PMA / PMN Number
    K051650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED WITH THE FDA ON SEPTEMBER 16, 2014. ADDITIONAL INFORMATION: BASED UPON THE ADDITIONAL INFORMATION, THE ISSUE WAS CONSISTENT WITH AN OUTLIER RESULT DUE TO SAMPLE HANDLING (MICROCLOTS, AGGLUTINATION, FIBRIN FORMATION) CAUSED THE FALSE ELEVATED RESULT OF 2.48 NG/ML. CUSTOMER SERVICE ENGINEER (CSE) PERFORMED PRECISION AND QC TESTING TO VERIFY INSTRUMENT OPERATION. CSE INDICATED THAT MESSAGE LOG WAS NOT AVAILABLE FOR REVIEW SO THE EVENT COULD NOT BE INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    SIEMENS FIELD SERVICE ENGINEER (FSE) COULD NOT COLLECT THE EVENT LOG BECAUSE INSTRUMENT WAS SWITCHED OFF. FSE PERFORMED REPEATABILITY TEST AND QUALITY CONTROL TEST AND ALL THE TROPONIN RESULTS WERE IN RANGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT 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
    570295 STRATUS CS STRATUS CS JHX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1