BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 6179544 · Received December 15, 2016

    Report

    Report Number
    2432235-2016-00770
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 15, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE REMOVED UNNECESSARY FILES FROM THE DRIVE AND RESTORED A DATABASE BACKUP. COMMUNICATION ISSUES WERE STILL OCCURRING. FURTHER EVALUATION BY THE CSE FOUND THE PROBLEM WAS RELATED TO THE NETWORK CARD. THE CSE REPLACED THE NETWORK CARD. THE CSE ALSO REPLACED THE "BACKUP" SERVER WITH ANOTHER SERVER THAT HAS MORE SPACE. THE CAUSE OF THE DELAY IN UPLOADING PATIENT RESULTS WAS DUE TO THE NETWORK CARD.THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEIR LOCAL "D" DRIVE WAS FULL, CAUSING A DELAY IN UPLOADING PATIENT SAMPLE RESULTS FROM THEIR CENTRALINK DATA MANAGEMENT SYSTEM. THE CUSTOMER ALSO STATED THERE WAS NO COMMUNICATION BETWEEN CENTRALINK AND THEIR LABORATORY INFORMATION SYSTEM (LIS), DELAYING 1,000 REQUESTS, LEAVING THEM IN THE VALIDATED STATUS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN UPLOADING PATIENT SAMPLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827336 CENTRALINK DATA MANAGEMENT SYSTEM DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1