BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS

    MDR report key: 5210921 · Received November 9, 2015

    Report

    Report Number
    1217157-2015-00160
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 8, 2015
    Report Date
    November 9, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DAP
    PMA / PMN Number
    K051650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVEN THOUGH SIEMENS MADE AWARE OF THIS COMPLAINT ON 10/08/2015; BASED ON THE INVESTIGATION AND ADDITIONAL INFORMATION RECEIVED, SIEMENS MEDICAL AFFAIRS IDENTIFIED THIS ISSUE AS LOW HEALTH RISK (LHR) ON 10/28/2015. AS PER PROCEDURE, SIEMENS DID RETROSPECTIVE REVIEW OF ALL ASSOCIATED COMPLAINTS WITH THIS ISSUE AND IDENTIFIED THOSE WITH POTENTIAL SAFETY ISSUES FOR WHICH MEDICAL DEVICE REPORTS NEED TO BE FILED. SIEMENS IS REVISING THE AFFECTED ACUTE CARE TESTPAK, CALPAK, AND DILPAK LABELING TO RESOLVE THIS ISSUE. SIEMENS IS PLANNING TO ISSUE AN URGENT FIELD SAFETY NOTICE TO NOTIFY AFFECTED SIEMENS CUSTOMERS ABOUT THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSTRUMENT WAS NOT READING TROPONIN TEST PAKS INTERMITTENTLY. CUSTOMER TRIED TO CALIBRATE ELEVEN DIFFERENT TROPONIN TEST PAKS FROM LOT 235215002 AND THEY DID NOT READ THREE IN A ROW IN ORDER TO CALIBRATE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741299 STRATUS CS STRATUS CS DAP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1