BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 3921425 · Received July 9, 2014

    Report

    Report Number
    2432235-2014-00413
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC DETERMINED THAT THE CAUSE OF THE EVENT IS DUE TO USER ERROR AS THE USER RELEASED A FLAGGED RETICULOCYTE RESULT OBTAINED FROM THE ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER WITHOUT REVIEWING IT FIRST. THE CUSTOMER FAILED TO FOLLOW OPERATOR GUIDE INSTRUCTIONS TO VALIDATE FLAGGED RESULTS AND TAKE APPROPRIATE ACTION IN ACCORDANCE WITH ESTABLISHED STANDARD OPERATING PROCEDURES BEFORE REPORTING PATIENT RESULTS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS INC AND REPORTED THAT THEY RELEASED A FLAGGED RETICULOCYTE RESULT TO THE PHYSICIAN THAT WAS OBTAINED ON AN ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER. THE FLAGGED RESULT WAS RELEASED WITHOUT ANY FURTHER CHECKS. THE CUSTOMER CONTACTED THE PHYSICIAN BUT THE PATIENT HAD ALREADY BEEN RELEASED FROM THE HOSPITAL. THE PATIENT WAS NOT CALLED BACK TO THE HOSPITAL NOR WAS READMITTED. THERE ARE NO KNOWN REPORTS OF ANY ADVERSE HEALTH CONSEQUENCES DUE TO THE FLAGGED RETICULOCYTE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401046 ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1