BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 4496021 · Received February 9, 2015

    Report

    Report Number
    2432235-2015-00062
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 15, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA. THE HSC DETERMINED THAT THE CENTRALINK INDICES ARE PRINTED AND DISPLAYED IN THE UNIVERSAL ORDER BUT THE E-CODES ARE NOT E111, E113 AND E112. THE E CODE FOR L (LIPEMIA) WAS ORIGINALLY E191 AS USED ON DIMENSION SYSTEMS. E191 IS A GENERIC HIL FLAG USED BY THE DIMENSION RXL. SIEMENS REMOVED THE CENTRALINK E191 FLAG AND REPLACED IT WITH E112. THE CAUSE OF THE E FLAG CONFIGURATION AND HIL, HLI INDICES LEADING TO MISINTERPRETATION OF PATIENT RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CENTRALINK PATIENT REPORTS MAY HAVE BEEN REPORTED WITH AN INCORRECT COMMENT THAT MAY LEAD TO MISINTERPRETATION OF PATIENT RESULTS. THE CUSTOMER STATED THAT THE INDICES ARE KNOWN GLOBALLY AS HIL IN THAT ORDER (HAEMOLYSIS, ICTERIC, LIPAEMIA) AND THE ERROR CODES FROM THE CUSTOMER'S DIMENSION VISTA INSTRUMENT ARE HLI (HAEMOLYSIS, LIPAEMIA, ICTERIC). THE CUSTOMER ALSO REPORTED THAT THE "E" FLAGS ARE THOSE GENERATED BY THE DIMENSION VISTA SYSTEM. HOWEVER, THE "E" FLAG FOR ICTERIC RESULTS WAS NOT E112 AND SHOULD HAVE BEEN E113. THE "E" FLAG FOR LIPAEMIC RESULTS WAS NOT E113 AND SHOULD HAVE BEEN E112. CONSEQUENTLY, THERE IS A POSSIBILITY THAT COMMENTS ASSOCIATED WITH ICTERIC AND LIPAEMIC SAMPLES MAY HAVE BEEN RELEASED INCORRECTLY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE E FLAG CONFIGURATION AND HIL, HLI INDICES CONFIGURATION ON CENTRALINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92053 CENTRALINK DATA MANAGEMENT SYSTEM CENTRALINK DATA MANAGEMENT SYSTEM JQP SIEMENS HEALTHCARE DIAGNOSTICS CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1