BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 560 HEMATOLOGY SYSTEM

    MDR report key: 5681705 · Received May 26, 2016

    Report

    Report Number
    2432235-2016-00287
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    January 19, 2016
    Report Date
    June 20, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K111534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT THE ADVIA 560 HEMATOLOGY SYSTEM PERFORMED AS EXPECTED WHEN SENDING HIGH, FLAGGED RESULTS TO THE LABORATORY INFORMATION SYSTEM (LIS) WHEN USING THE HL7 (HEALTH LEVEL-7) PROTOCOL. THE ADVIA 560 HEMATOLOGY SYSTEM COMMUNICATION PROTOCOL GUIDE REVISION A STATES "ADVIA 560 IS ABLE TO SEND MEASUREMENT RESULTS TO AND RECEIVE SO-CALLED "WORK LISTS" FROM A REMOTE COMPUTER. TO ACTIVATE AND USE THIS FEATURE, THE INSTRUMENT NEEDS TO BE CONNECTED TO A HL7 CAPABLE SERVER DIRECTLY OR THROUGH A COMPUTER LOCAL AREA NETWORK (LAN)." WHEN USING AN HL7 PROTOCOL, THE ADVIA 560 HEMATOLOGY SYSTEM DOES NOT SEND FLAGS TO A REMOTE COMPUTER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR (2432235-2016-00287) ON MAY 26, 2016.MAY 30, 2016, CORRECTED DATA/ADDITIONAL INFORMATION:SIEMENS HEALTHCARE DIAGNOSTICS INC. IS CORRECTING THE DATE OF EVENT FROM (B)(6) 2016 TO (B)(6) 2016 AND PROVIDING THE COMPLETE CONTACT INFORMATION.

    Description of Event or Problem · 1

    A HIGH, FLAGGED WHITE BLOOD CELL (WBC) COUNT THAT WAS OBTAINED ON THE ADVIA 560 HEMATOLOGY SYSTEM WAS TRANSFERRED TO THE LABORATORY INFORMATION SYSTEM (LIS) WITHOUT THE FLAGS. THE PATIENT SAMPLE WAS NOT DILUTED PRIOR TO REPORTING THE PATIENT RESULTS TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULTS. THE CUSTOMER IS USING THE HEALTH LEVEL-7 (HL7) PROTOCOL TO TRANSFER RESULTS FROM THE ADVIA 560 HEMATOLOGY SYSTEM TO THE LIS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH, FLAGGED WBC COUNT OBTAINED ON THE ADVIA 560 HEMATOLOGY SYSTEM BEING REPORTED TO THE PHYSICIAN WITHOUT DILUTING THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336449 ADVIA 560 HEMATOLOGY SYSTEM ADVIA 560 HEMATOLOGY SYSTEM GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1