BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 9383448 · Received November 27, 2019

    Report

    Report Number
    2432235-2019-00435
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 27, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT DISCORDANT COMPLETE BLOOD COUNT (CBC) PARAMETERS WERE OBTAINED ON ELEVEN PATIENT SAMPLES ON AN ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE. THE CSE PERFORMED CHECKS FOR HYDRAULICS, OPTICS, AND LEAKS. THE CBC RESULTS IMPROVED AFTER REPLACING THE SHEATH RINSE. THE CSE VERIFIED ACCEPTABLE SYSTEM PERFORMANCE AND RAN QUALITY CONTROLS (QC), WHICH RECOVERED WITHIN RANGE. THE PROBABLE CAUSE OF THE EVENT WAS A LACK CONTINUOUS FLOW OF SHEATH RINSE, WHICH PULLED AIR INTO THE SYSTEM AND CAUSED DISCORDANT RESULTS TO BE OBTAINED. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT COMPLETE BLOOD COUNT (CBC) PARAMETERS WERE OBTAINED ON ELEVEN PATIENT SAMPLES ON AN ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT PARAMETERS INCLUDE WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), MEAN CORPUSCULAR VOLUME (MCV), MEAN CORPUSCULAR HEMOGLOBIN (MCH), MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC), CORPUSCULAR HEMOGLOBIN CONCENTRATION MEAN (CHCM), RED CELL DISTRIBUTION WIDTH (RDW), HEMOGLOBIN DISTRIBUTION WIDTH (HDW), PLATELETS (PLT), MEAN PLATELET VOLUME (MPV), NEUTROPHILS (NEUT), LYMPHOCYTES (LYMPH), MONOCYTES (MONO), BASOPHILS (BASO), LARGE UNSTAINED CELLS (LUC), AND NUCLEATED RED BLOOD CELLS (NRBC). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED BY THE PHYSICIAN(S). THE ORIGINAL SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA 2120 HEMATOLOGY SYSTEM AND WERE ALSO REPEATED ON THE ORIGINAL SYSTEM. THE REPEAT RESULTS OBTAINED WERE CONSIDERED CORRECT AND MATCHED THE PATIENTS' CLINICAL HISTORIES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT COMPLETE BLOOD COUNT (CBC) PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179844 ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1