BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH AUTOSAMPLER

    MDR report key: 3031635 · Received April 2, 2013

    Report

    Report Number
    2432235-2013-00106
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    April 2, 2012
    Report Date
    March 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS INVESTIGATED THE MCV REPORTED ISSUE. THE CUSTOMER COMPLAINT WAS EVALUATED AND THE DEVICE WAS FOUND TO BE PERFORMING WITHIN SPECIFICATION. STUDIES CONDUCTED BY SIEMENS HAVE CONFIRMED THE ACCURACY OF CALIBRATION OF ADVIA HEMATOLOGY INSTRUMENTS WHEN COMPARED TO THE CLSI STANDARD METHOD FOR MICROHEMATOCRIT. IN ADDITION, A COMPARATIVE STUDY TO ANOTHER COMPETITIVE HEMATOLOGY INSTRUMENT IN ROUTINE USE AT THE CUSTOMER LAB SHOWED THAT THE TWO SYSTEMS COMPARED VERY CLOSELY WITH A 1.4 FEMTOLITER DIFFERENCE BETWEEN THE MCV RESULTS. THE OBSERVED DIFFERENCE IS WELL WITHIN THE EXPECTED DIFFERENCE FOR MCV BETWEEN TWO HEMATOLOGY SYSTEMS IN A COMPARATIVE STUDY. THIS MDR IS BEING FILED IN RESPONSE TO USER FACILITY MEDWATCH (B)(4).

    Description of Event or Problem · 1

    (B)(6) HAS REPORTED PROBLEMS PERTAINING TO MEAN CORPUSCULAR VOLUME (MCV) ASSAY PERFORMANCE ON THE SIEMENS ADVIA 2120I HEMATOLOGY ANALYZER. PHYSICIANS HAVE STATED THAT THE MCV'S REPORTED BY SIEMENS ADVIA HEMATOLOGY 2120I INSTRUMENTS WERE FALSELY ELEVATED. (B)(6) INTERNAL INVESTIGATION DETERMINED MCV RESULTS WERE 3-4 FEMTOLITER (FL) HIGHER SINCE 2011. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED MCV RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134756 ADVIA 2120I WITH AUTOSAMPLER HEMATOLOGY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I

    Patients

    Seq Age Sex Outcome Treatment
    1