BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 560 HEMATOLOGY SYSTEM

    MDR report key: 9412092 · Received December 4, 2019

    Report

    Report Number
    2432235-2019-00442
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 7, 2019
    Report Date
    January 9, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    UDI-DI
    00630414601816
    PMA / PMN Number
    K112755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00442 ON 04-DEC-2019. ADDITIONAL INFORMATION (06-JAN-2020): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE REPLACED THE SYSTEM AMPLIFIER BOARD AS WELL AS THE RED BLOOD CELL (RBC) MEASURE CHAMBER. AFTER THE PARTS WERE INSTALLED, THE CSE CHECKED THE SYSTEM ELECTRONICS AND PNEUMATICS, BOTH OF WHICH WERE ACCEPTABLE. THE PROBABLE CAUSE OF THE EVENT WAS A SAMPLE SPECIFIC ISSUE; HOWEVER, SIEMENS CANNOT RULE OUT THE TWO REPLACED PARTS AS A POSSIBLE CAUSE OF THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT DISCORDANT HEMOGLOBIN (HGB), HEMATOCRIT (HCT), RED BLOOD CELLS (RBC), AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 560 HEMATOLOGY SYSTEM. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    DISCORDANT HEMOGLOBIN (HGB), HEMATOCRIT (HCT), RED BLOOD CELLS (RBC), AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 560 HEMATOLOGY SYSTEM COMPARED TO RESULTS GENERATED ON THE LAB'S ADVIA 2120I HEMATOLOGY SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE HGB, HCT, RBC, AND RDW RESULTS OBTAINED ON THE LAB'S ADVIA 2120I HEMATOLOGY SYSTEM WERE CONSIDERED CORRECT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HEMOGLOBIN (HGB), HEMATOCRIT (HCT), RED BLOOD CELLS (RBC), AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205695 ADVIA 560 HEMATOLOGY SYSTEM ADVIA 560 HEMATOLOGY SYSTEM GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM 00630414601816

    Patients

    Seq Age Sex Outcome Treatment
    1