BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 3831261 · Received May 23, 2014

    Report

    Report Number
    2432235-2014-00346
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC ANALYZED THE INSTRUMENT DATA AND DETERMINED THAT ONCE THE CUSTOMER FOLLOWED THE OPERATOR'S GUIDE PERTAINING TO QC AND QC INSTRUMENT FLAG SEVERITY, THE QC SEVERITY ON INSTRUMENT FLAGS WAS CORRECTED. THE OPERATOR'S GUIDE STATES THAT THE SEVERITIES ARE ASSIGNED IN THE WESTGARD SETUP SUB-TAB OF THE ADVANCED TAB OF THE METHOD WINDOW. THE CAUSE OF THE INCORRECT QC SEVERITY ON INSTRUMENT FLAGS MAKING WESTGARD RULES INEFFECTIVE IS UNKNOWN. THE TSC REMINDED THE CUSTOMER TO FOLLOW THE OPERATOR'S GUIDE FOR CORRECT QC AND QC INSTRUMENT SEVERITY FLAGS. THE ADVIA CENTRALINK DATA MANAGEMENT SYSTEM IS PERFORMING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308509 CENTRALINK DATA MANAGEMENT SYSTEM CENTRALINK DATA MANAGEMENT SYSTEM JQP SIEMENS HEALTHCARE DIAGNOSTICS CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1