BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 4747286 · Received May 5, 2015

    Report

    Report Number
    2432235-2015-00225
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINICAL SERVICE ENGINEER (CSE) VISITED THE CUSTOMER SITE TO TROUBLESHOOT THE ERRATIC MEAN CORPUSCULAR VOLUME (MCV) RESULTS ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE CSE CHECKED THE INSTRUMENT FLUIDS, PERFORMED AN OPTICS CHECK, REPLACED THE PEROX LAMP, ADJUSTED A LOOSE SCREW FROM THE RED BLOOD CELL (RBC)/BASO/RETIC OPTICS BENCH AND REPLACED THE CONCENTRIC FLOW MODULE. THE CSE THEN VERIFIED THE GAINS VERSUS TARGET VALUES, RAN CONTROLS, WHICH PASSED SPECIFICATIONS, AND PERFORMED A PATIENT CORRELATION WITH THE OTHER ADVIA 2120 INSTRUMENT IN THE LABORATORY. THE CAUSE OF THE MCV DELTA CHECK FAILURE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MEAN CORPUSCULAR VOLUME (MCV) DELTA CHECK IS FAILING ON SOME PATIENT SAMPLES WHEN RUN ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. NO PATIENT DATA OR QUALITY CONTROL DATA WAS PROVIDED BY THE CUSTOMER. HOWEVER, THE CUSTOMER STATED THAT THE QUALITY CONTROL MATERIAL WAS NOT AFFECTED. THE AFFECTED PATIENT SAMPLES WERE NOT REPORTED TO THE PHYSICIAN(S). THE AFFECTED PATIENT SAMPLES WERE RUN ON THE BACKUP ADVIA 2120 INSTRUMENT AND THE MCV DELTA CHECKS PASSED. THE RE-RUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF PATIENT SAMPLES WITH NO PREVIOUS HISTORY IN THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) WERE REPORTED OUT WITH AN INCORRECT MCV RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE MCV DELTA CHECK FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292779 ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1