BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 6015797 · Received October 10, 2016

    Report

    Report Number
    2432235-2016-00610
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 10, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SUPPORT TECHNICIAN (TST) REVIEWED THE EVENT. THE TST CHECKED THE TEST NORMS SETTINGS, AND THEY WERE CORRECT. THE TST HAD THE CUSTOMER FIND A SAMPLE IDENTIFICATION NUMBER AND ENTER IT INTO THEIR CENTRALINK SYSTEM. THE TST REVIEWED THE REVISION AND EDIT SCREEN AND FOUND NO SEVERITIES WERE TRIGGERED. THE TST REQUESTED THE CUSTOMER TO OPEN THE METHOD ON THE INSTRUMENT ICON, BUT THE CUSTOMER STATED THERE WAS NO ICON. THE TST THEN REQUEST THE CUSTOMER TO OPEN THE TEST FOR PTT. THE TST FOUND THAT THE AUTO-VALIDATION FOR NORM SEVERITY (NS) WAS SET TO 2. THE NORM IS SET TO 9 SEVERITY. IT IS UNKNOWN WHO CHANGED TO SETTING TO 0 AS LOG AUDITING WAS NOT ENABLED AT THE TIME OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE WORKED THROUGH MULTIPLE SETTINGS AND FOUND SETTINGS FOR THE NORM SEVERITY WAS SET TO 0. THE CSE CORRECTED THE SETTING TO 9. THE CUSTOMER'S TECHNICIAN RAN SAMPLES TO VERIFY CORRECTION. THE INSTRUMENT WAS PROPERLY AUTO-VALIDATING SAMPLES AND HOLDING SAMPLES ACCORDING TO SEVERITY SETTINGS. THE CAUSE OF THE ELEVATED PARTIAL THROMBOPLASTIN TIME RESULTS AUTO-VALIDATING WAS DUE TO CENTRALINK'S NORM SEVERITY SETTING BEING IMPROPERLY SET. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    MULTIPLE ELEVATED PARTIAL THROMBOPLASTIN TIME (PTT) RESULTS WERE AUTO-VALIDATED IN A CUSTOMER'S CENTRALINK DATA MANAGEMENT SYSTEM. THE CUSTOMER SUPPLIED ONE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS NOT REPORTED OUT TO THE PHYSICIAN(S). THE SAMPLE WAS NOT REPEATED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED PARTIAL THROMBOPLASTIN TIME RESULTS BEING AUTO-VALIDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665556 CENTRALINK DATA MANAGEMENT SYSTEM DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1