BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA DATA MANAGER

    MDR report key: 18401688 · Received December 27, 2023

    Report

    Report Number
    2432235-2023-00339
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    December 13, 2023
    Report Date
    March 12, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) SIEMENS CSE (CUSTOMER SERVICE ENGINEER) REPORTED THAT THE ADM (ATELLICA DATA MANAGER WITH S/N: (B)(6), CONNECTED TO DMS (DATA MANAGEMENT SOFTWARE), CREATED AN UNKNOWN PATIENT ID AND REPLACED PATIENT DEMOGRAPHICS WITH INCORRECT DATA AND TEST RESULTS. SIEMENS INVESTIGATED THE EVENT AND NOTED THE SAMPLES RAN IN THE PAST, SEVERAL MONTHS AGO, AND WERE ARCHIVED AS PER SYSTEM CONFIGURATION. THE CUSTOMER NOTED NO DELAY IN TESTING AND REPORTING RESULTS, AND THE EVENT DID NOT AFFECT STAT SAMPLE TESTING. THE DISCORDANT RESULTS DID NOT REACH THE CUSTOMER LIS (LABORATORY INFORMATION SYSTEM). ON 11-DEC-2023, SIEMENS NOTED THAT RESULTS WERE SENT FROM THE ATS1, CAUSING DMS TO RECOGNIZE THEM AS UNKNOWN SAMPLES AND CREATE UNKNOWN PATIENT IDS. THE SAMPLES WERE SENT TO ADM, AND IT SENT THEM TO THE LIS WITH THE REAL SAMPLE ID BUT THE UNKNOWN PATIENT ID. SINCE THE SAMPLES ALREADY HAVE A VALIDATED RESULT ON THE LIS, AND NO FURTHER RESULTS WERE REQUESTED, THE SYSTEM DID NOT TAKE THE NEW RESULTS. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00339 ON 27-DEC-2023. ADDITIONAL INFORMATION ON (28-FEB-2024): SIEMENS EVALUATED THE INFORMATION AND CONFIRMED THAT THERE WAS NO ATELLICA DATA MANAGER (ADM) MALFUNCTION AND THAT THE RESULTS WERE BEING SENT FROM THE ATELLICA SOLUTION, AS INTENDED. THE ADM IS WORKING AS INTENDED, AND THERE WAS NO PRODUCT PROBLEM.

    Description of Event or Problem · 0

    A SIEMENS CSE (CUSTOMER SERVICE ENGINEER) REPORTED THAT THE ADM (ATELLICA DATA MANAGER WITH S/N: (B)(6), CONNECTED TO DMS (DATA MANAGEMENT SOFTWARE), CREATED AN UNKNOWN PATIENT ID AND REPLACED PATIENT DEMOGRAPHICS WITH INCORRECT DATA AND TEST RESULTS. 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
    2292573 ATELLICA DATA MANAGER ATELLICA DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA DATA MANAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown