BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 560 HEMATOLOGY SYSTEM

    MDR report key: 5448021 · Received February 19, 2016

    Report

    Report Number
    2432235-2016-00093
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    February 2, 2016
    Report Date
    February 3, 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. (SIEMENS) FILED THE INITIAL MDR (2432235-2016-00093) ON FEBRUARY 19, 2016. APRIL 11, 2016, ADDITIONAL INFORMATION: SIEMENS' INVESTIGATION INTO CAUSE OF THE PATIENT SAMPLE IDENTIFICATION (SID) NUMBER BEING MIS-READ ON THE ADVIA 560 HEMATOLOGY SYSTEM DETERMINED THAT THE BARCODE SYMBOLOGY USED IS CORRECT. FURTHER INVESTIGATION COULD NOT BE ACCOMPLISHED AS THE CUSTOMER COULD NOT PROVIDE THE ORIGINAL BARCODE IMPLICATED IN THIS EVENT AS IT WAS DISCARDED. THE CAUSE OF THE PATIENT SAMPLE IDENTIFICATION (SID) NUMBER BEING MIS-READ ON THE ADVIA 560 HEMATOLOGY SYSTEM IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE BARCODE MIS-READ ON ONE PATIENT SAMPLE ON THE ADVIA 560 HEMATOLOGY SYSTEM.

    Description of Event or Problem · 1

    A PATIENT SAMPLE IDENTIFICATION (SID) NUMBER WAS MIS-READ ON THE ADVIA 560 HEMATOLOGY SYSTEM. DURING VALIDATION OF THE PATIENT RESULTS, THE CUSTOMER NOTED THAT THERE WAS A DIFFERENCE BETWEEN THE MEASURED RESULTS AND THE RESULTS FROM THE PREVIOUS DAY FOR THE SAME PATIENT. THE CUSTOMER VERIFIED THE SID ON THE PATIENT SAMPLE AND FOUND THAT IT WAS DIFFERENT THAN THE SID RECORDED IN THE INSTRUMENT. THE PATIENT SAMPLE SID (B)(4) WAS READ AS SID (B)(4). THE INCORRECT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER RERAN THE SAME PATIENT SAMPLE ON THE SAME ADVIA 560 HEMATOLOGY SYSTEM AND THE SID WAS READ CORRECTLY AND THE RESULTS MATCHED THE PREVIOUS DAY'S RESULTS FOR THE SAME PATIENT. THE CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SID BARCODE MIS-READ ON THE ADVIA 560 HEMATOLOGY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104216 ADVIA 560 HEMATOLOGY SYSTEM ADVIA 560 HEMATOLOGY SYSTEM GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1