BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 18192785 · Received November 22, 2023

    Report

    Report Number
    2432235-2023-00308
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    November 15, 2023
    Report Date
    February 15, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (27-NOV-2023): SECTION D; BRAND NAME (D1), COMMON DEVICE NAME (D2), PRODUCT CODE (D2), AND MODEL NUMBER (D4) WERE CORRECTED TO REFLECT THE CORRECT PRODUCT, ATELLICA SAMPLE HANDLER PRIME.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00308 ON 22-NOV-2023. ADDITIONAL INFORMATION (08-FEB-2024): SIEMENS FURTHER INVESTIGATED AND A REVIEW INDICATED THE DEVICE MANAGEMENT LAYER (DML) ENCOUNTERED AN INTERNAL EXCEPTION CAUSING THE MODULE TO TURN OFF UNEXPECTEDLY. IN THESE CASES, THE MODULE MANAGER (MM) WILL DETECT THAT THE DML IS UNRESPONSIVE AND WILL RESTART. UPON RESTARTING, ANY UNCOMPLETED TESTS WOULD BE 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. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF UNITED STATES (OUS) CUSTOMER REPORTED AN UNAPPARENT DELAY WITH TROPONIN AND HUMAN CHORIONIC GONADOTROPIN PATIENT RESULTS WITH AN ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND A SIEMENS REMOTE SERVICES WAS ABLE TO SPEAK WITH THE CUSTOMER. SIEMENS IS INVESTIGATING THE ISSUE. THIS REPORT SERVES AS A CORRECTION TO REPORT #2247117-2023-00006 FILED ON NOVEMBER 21, 2023. THE FDA REPORTING SITE IN THE PREVIOUS REPORT WAS INCORRECT AND HAS BEEN CORRECTED IN THIS REPORT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN UNAPPARENT DELAY OCCURRED WITH ONE HUMAN CHORIONIC GONADOTROPIN PATIENT RESULT WITH AN ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER FOUND THE SAMPLES WERE NOT PROCESSED. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO PATIENT CARE DUE TO THE DELAY. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232282 ATELLICA SAMPLE HANDLER PRIME ATELLICA SAMPLE HANDLER PRIME JJE SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA SAMPLE HANDLER PRIME 00630414002439
    1757763 ATELLICA SAMPLE HANDLER PRIME ATELLICA SAMPLE HANDLER PRIME JJE SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown