BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 13545891 · Received February 16, 2022

    Report

    Report Number
    2432235-2022-00044
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 23, 2022
    Report Date
    February 16, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER AND NOTED THAT AN OPERATOR RESTARTED THE PRIME PROCESS CONTROL COMPUTER (PCC) AND LOST COMMUNICATION WITH THE SAMPLE HANDLER CONNECT (SHC) AND THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) ON THE CONNECTED ATELLICA CHEMISTRY (CH) MODULES. THE OPERATOR PERFORMED A HARD SHUTDOWN TO RESTORE THE COMMUNICATION AND RESOLVE THE ISSUE. SIEMENS REVIEWED THE INFORMATION PROVIDED AND NOTED THE OPERATOR RESOLVED THE ISSUE. SIEMENS NOTED THAT THE ATELLICA SAMPLE HANDLER PRIME AND CONNECTED ANALYZERS PERFORM AS EXPECTED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER NOTED THE ATELLICA SAMPLE HANDLER PRIME PROCESS CONTROL COMPUTER (PCC) LOST COMMUNICATION WITH OTHER ANALYZERS COMPUTERS AND THAT EMERGENCY ROOM PATIENT RESULTS WERE DELAYED BY 5 HOURS. THE CUSTOMER INFORMED SIEMENS THAT ALL TESTS ON THE CONNECTED ATELLICA ANALYZERS WERE IMPACTED AND DID NOT PROVIDE THE AFFECTED TESTS AND SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN TESTING AND REPORTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173258 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 Unknown