BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA DATA MANAGER

    MDR report key: 19449241 · Received June 3, 2024

    Report

    Report Number
    2432235-2024-00123
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 19, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ATELLICA DATA MANAGER CUSTOMER REPORTED THAT ORDERS WERE NOT DISPATCHED TO THE LABORATORY AUTOMATION SYSTEM (LAS). THE ATELLICA DATA MANAGER WITH SERIAL NUMBER (B)(6) IS CONNECTED WITH THE DATA MANAGEMENT SYSTEM (DMS), AND THE CUSTOMER REPORTED THAT A BACKUP INSTRUMENT OR ALTERNATE METHOD TO TEST PATIENT SAMPLES OR REPORT RESULTS WAS NOT AVAILABLE. THE EVENT CAUSED A 2-HOUR DELAY AND AFFECTED STAT SAMPLE(S). SIEMENS ASSISTED THE CUSTOMER AND IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2024-00123 ON 03-JUN-2024. ADDITIONAL INFORMATION (05-JUN-2024): SIEMENS EVALUATED THE INFORMATION PROVIDED AND RECEIVED THE CUSTOMER'S PERMISSION TO CONNECT REMOTELY AND INVESTIGATE THE ATELLICA DATA MANAGER SYSTEM. SIEMENS PERFORMED TROUBLESHOOTING, WHICH INCLUDED CHECKING THE HOST FILE AND WAS CORRECT, REMOVING THE QUEUE PROCESSOR AND MESSAGE QUEUE FROM THE LAS DISPATCH PROCESS, AND DISABLING THE IPV6 FROM THE NETWORK PROPERTIES. THE ISSUE DID NOT RECUR, AND THE ATELLICA DATA MANAGER IS OPERATING AS SPECIFIED. THE POTENTIAL CAUSE OF THE EVENT IS UNKNOWN, AND NO FURTHER ACTION IS REQUIRED. SIEMENS UPDATED SECTION H6 (INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS) TO REFLECT THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE ATELLICA DATA MANAGER CUSTOMER REPORTED THAT ORDERS WERE NOT DISPATCHED TO THE LABORATORY AUTOMATION SYSTEM (LAS). THE ATELLICA DATA MANAGER WITH SERIAL NUMBER (B)(6) IS CONNECTED WITH THE DATA MANAGEMENT SYSTEM (DMS), AND THE CUSTOMER REPORTED THAT A BACKUP INSTRUMENT OR ALTERNATE METHOD TO TEST PATIENT SAMPLES OR REPORT RESULTS WAS NOT AVAILABLE. THE EVENT CAUSED A 2-HOUR DELAY AND AFFECTED STAT SAMPLE(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992496 ATELLICA DATA MANAGER ATELLICA DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA DATA MANAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown