BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 560 HEMATOLOGY SYSTEM

    MDR report key: 6552334 · Received May 8, 2017

    Report

    Report Number
    2432235-2017-00303
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 17, 2017
    Report Date
    May 8, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K112755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTIC INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO DETERMINE THE CAUSE OF THE SID MISREADING ON THE ADVIA 560 HEMATOLOGY SYSTEM. THE CUSTOMER HAD NO PRIOR INCIDENTS OF AN INCORRECT SID BEING ASSIGNED TO A PATIENT SAMPLE. THE CAUSE OF THE EVENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSTIC INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) OBSERVED A DISCREPANCY IN SID READING FOR THE SAME PATIENT SAMPLE WHILE TROUBLESHOOTING A SAMPLE FLAG ON THE ADVIA 560 HEMATOLOGY SYSTEM. A RACK (RACK A) OF 10 PATIENT SAMPLES WAS RUN ON THE ADVIA 560 HEMATOLOGY SYSTEM TWICE. DURING THE FIRST RUN OF RACK A AT POSITION 5, THE AUTOLOADER BARCODE READ (B)(6). DURING THE SECOND RUN OF RACK A AT POSITION 5, THE AUTOLOADER BARCODE READ (B)(6). THE CORRECT SID FOR RACK A AT POSITION 5 IS (B)(6). THE PATIENT RESULTS FOR THIS INCIDENT WERE CORRECTLY REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHETHER THE CUSTOMER REPORTED WRONG RESULTS TO THE PHYSICIAN PRIOR TO THIS INCIDENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANCY OF PATIENT SAMPLE'S SID READINGS ON THE ADVIA 560 HEMATOLOGY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333012 ADVIA 560 HEMATOLOGY SYSTEM ADVIA 560 HEMATOLOGY SYSTEM GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1