BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 18112592 · Received November 10, 2023

    Report

    Report Number
    2432235-2023-00294
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 31, 2023
    Report Date
    July 26, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATELLICA SAMPLE HANDLER PRIME CUSTOMER NOTED THAT SAMPLE (B)(6) RECEIVED AT 12:39 P.M. ON 31-OCT-2023 WAS NOT PROCESSED AND ANALYZED WITH TNIH (HIGH-SENSITIVITY TROPONIN I) AND CAUSED A DELAY IN THE ASSESSMENT OF THE PATIENT. THE CUSTOMER PERFORMED REPEAT TESTING AND NOTED THAT THE SAMPLE WAS TESTED ON AN ALTERNATE ATELLICA ANALYZER. THE TNIH RESULT WAS OBTAINED AT 16:14 P.M. AND RELEASED FROM THE LAB AT 16:25 P.M. ON 31-OCT-2023. SIEMENS RETRIEVED SYSTEM FILES AND IS EVALUATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00294 ON 10-NOV-2023. ADDITIONAL INFORMATION (16-JUL-2024): SIEMENS REVIEWED THE INFORMATION PROVIDED AND DETERMINED THAT THE ATELLICA IMMUNOASSAY (IM) ANALYZER WAS IN AN "OFF STATE" DUE TO A DEVICE MANAGER LAYER (DML) INTERNAL EXCEPTION. THE MODULE MANAGER (MM) DETECTS THAT THE DEVICE MANAGEMENT LAYER (DML) IS UNRESPONSIVE AND RESTARTS. UPON RESTART, ANY UNCOMPLETED TESTS ARE CANCELED. IN CASES WHERE THE SYSTEM DOES NOT RETURN TO NORMAL OPERATION AUTOMATICALLY, THE OPERATOR CAN TURN MECHANICS OFF/ON OR RESTART THE SYSTEM AND RE-ORDER THE TESTS MANUALLY. SIEMENS CONCLUDED THAT THE REPORTED BEHAVIOR WAS CAUSED BY AN INTERNAL SOFTWARE EXCEPTION AND RESULTED IN AN APPARENT DELAY THAT FAILED SAFE BY CANCELING UNREPORTED TESTS AND NOT AFFECTING TEST RESULT ACCURACY. SIEMENS NOTED THAT THE EVENT WAS AN ISOLATED OCCURRENCE AND THAT THE CUSTOMER HAS A BACKUP ANALYZER OR ALTERNATE METHOD TO TEST PATIENT SAMPLES AND REPORT RESULTS.

    Description of Event or Problem · 0

    AN ATELLICA SAMPLE HANDLER PRIME CUSTOMER NOTED THAT SAMPLE (B)(6) RECEIVED AT 12:39 P.M. ON 31-OCT-2023 WAS NOT PROCESSED AND ANALYZED WITH TNIH (HIGH-SENSITIVITY TROPONIN I) AND CAUSED A DELAY IN THE ASSESSMENT OF THE PATIENT. THE CUSTOMER PERFORMED REPEAT TESTING AND NOTED THAT THE SAMPLE WAS TESTED ON AN ALTERNATE ATELLICA ANALYZER. THE TNIH RESULT WAS OBTAINED AT 16:14 P.M. AND RELEASED FROM THE LAB AT 16:25 P.M. ON 31-OCT-2023. 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
    1805931 ATELLICA SAMPLE HANDLER PRIME ATELLICA SAMPLE HANDLER PRIME JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown