BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SOLUTION

    MDR report key: 10271772 · Received July 14, 2020

    Report

    Report Number
    2432235-2020-00343
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 6, 2020
    Report Date
    August 24, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2020-00343 WAS FILED ON 14-JUL-2020. ADDITIONAL INFORMATION (10-AUG-2020): THE CUSTOMER CONTACTED SIEMENS TO REPORT THEY WERE NO LONGER EXPERIENCING THE CONNECTIVITY ISSUE AND REQUESTED TO CLOSE THE CALL. THE CAUSE OF THE ATELLICA SAMPLE HANDLER PRIME (SHP) REBOOTING UNEXPECTEDLY IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS NEEDED. SECTION H6 CONCLUSION CODE WAS UPDATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT THE ATELLICA SAMPLE HANDLER PRIME (SHP) REBOOTED UNEXPECTEDLY CREATING A DELAY IN THE PROCESSING OF PATIENT SAMPLES. THE CUSTOMER REPORTED THAT THE SHP DISPLAYED A BLUE SCREEN WITH A WHITE HOURGLASS AND A MESSAGE STATING THE SYSTEM SHUT ITSELF DOWN. AFTER AUTO-RECOVERY, THE SHP DISPLAYED A TUBE CHARACTERIZATION STATION (TCS) ERROR AND THE SHP WAS NOT COMMUNICATING WITH THE AUTOMATION SYSTEM. A MANUALLY INITIATED REBOOT OF THE PROCESS CONTROL COMPUTER (PCC) RESOLVED THE TCS ISSUE AND THE COMMUNICATION WITH THE AUTOMATION SYSTEM ISSUE. THE REPORTED DELAY IN TESTING IS THE PERIOD DURING WHICH THE ATELLICA SAMPLE HANDLER PRIME (SHP) WAS UNABLE TO RECEIVE SAMPLES FROM THE AUTOMATION SYSTEM. SIEMENS IS INVESTIGATING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS AND STATED AN ATELLICA SAMPLE HANDLER PRIME (SHP) REBOOTED UNEXPECTEDLY CREATING A DELAY IN THE PROCESSING OF PATIENT SAMPLES FROM THE AUTOMATION SYSTEM. THE CUSTOMER DID NOT PROVIDE TEST AND PATIENT DATA. THERE WERE NO DISCORDANT RESULTS. AN ALTERNATE ATELLICA SYSTEM WAS UNAVAILABLE FOR TESTING DUE TO MAINTENANCE ACTIVITY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN PROCESSING SAMPLES AND PATIENT CARE. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED BY SIEMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734254 ATELLICA SOLUTION ATELLICA SOLUTION JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1