BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 5080821 · Received September 16, 2015

    Report

    Report Number
    2432235-2015-00404
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    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. (SIEMENS) INVESTIGATION DETERMINED THAT THE CUSTOMER FAILED TO FOLLOW OPERATOR GUIDE INSTRUCTIONS WHEN THEY RELEASED A FLAGGED PERCENT RETICULOCYTE (%RETIC) RESULT OBTAINED ON ONE SAMPLE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE OPERATOR GUIDE INSTRUCTIONS STATE "WHENEVER A FLAG IS TRIGGERED, THE USER SHOULD REVIEW THE RESULTS AND TAKE APPROPRIATE ACTION." THE FLAGGED RESULT SHOULD HAVE BEEN CONFIRMED ON THE INSTRUMENT CONCERNED PRIOR TO RELEASING THE RESULTS TO THE PHYSICIAN. SIEMENS ADVISED THE CUSTOMER THAT A MANUAL COUNT SHOULD BE PERFORMED WHEN THERE ARE FLAGS OR IF THE SCATTERGRAMS INDICATE A NEED FOR A MANUAL COUNT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW FLAGGED PERCENT RETICULOCYTE (%RETIC) RESULT OF 0 WAS OBTAINED ON ONE PATIENT SAMPLE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE FLAGGED %RETIC RESULT WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THE PHYSICIAN QUESTIONED THE RESULT. NO PATIENT DATA WAS PROVIDED BY THE CUSTOMER. THE PATIENT RECEIVED ERYTHROPOIETIN (EPO) AS A TREATMENT AS THEY SUSPECTED THAT THE PATIENT WAS APLASTIC BASED ON THE 0%RETIC RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE PATIENT RECEIVING EPO BECAUSE OF THE DISCORDANT, FALSELY LOW %RETIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611015 ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1