BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 10680629 · Received October 14, 2020

    Report

    Report Number
    2432235-2020-00414
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 22, 2020
    Report Date
    November 17, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2020-00414 ON 14-OCT-2020. ADDITIONAL INFORMATION (23-OCT-2020): SIEMENS REVIEWED THE INFORMATION PROVIDED AND SYSTEM FILES. IT WAS DETERMINED THAT A JAM IN THE CUVETTELOADER OCCURRED, AND THE TEST SCHEDULED FOR SAMPLE 350445 WAS CANCELED BECAUSE CUVETTES WERE NOT AVAILABLE FOR PROCESSING. SIEMENS DETERMINED THAT THE ATELLICA SAMPLE HANDLER PRIME PERFORMED AS SPECIFIED AND IDENTIFIED NO PRODUCT ISSUE. THE CUSTOMER HAS RESTARTED THE PROCESS CONTROL COMPUTER (PCC) AND RESOLVED THE ISSUE. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND INFORMED THAT THE DELAY WAS 1-2 HOURS. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER NOTED THAT PUCKS ON THE ATELLICA SAMPLE HANDLER PRIME STOPPED MOVING WITHOUT ERROR, WHILE THE ATELLICA MODULE WAS IN THE READY OR THE PROCESSING STATE. ON THE FOLLOWING MORNING ((B)(6) 2020), BETWEEN 7:30 A.M. AND 8:00 A.M., THE CUSTOMER RESTARTED THE ATELLICA AND NOTED IT WAS IN THE READY STATE. THE CUSTOMER LOADED A STAT SAMPLE ON A PUCK ON THE ATELLICA SAMPLE HANDLER PRIME, AND THE PUCK STOPPED AT THE DEFAULT WAITING QUEUE (DWQ). THE CUSTOMER NOTED THAT THE STAT SAMPLE DID NOT PROCESS AND THAT OTHER SAMPLES LOADED THROUGH THE SAMPLE HANDLER CONNECT (SHC) WERE NOT PROCESSED AND REMAINED ON THE DWQ. THE CUSTOMER PERFORMED TROUBLESHOOTING, RESTARTED THE PROCESS CONTROL COMPUTER (PCC), AND RESOLVED THE ISSUE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN STAT TESTING AND REPORTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145381 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