BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 5323418 · Received December 23, 2015

    Report

    Report Number
    2432235-2015-00589
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    November 24, 2015
    Report Date
    December 1, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2015-00589) ON 12/26/2015. ON 01/21/2016 - ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) INVESTIGATION FOUND THAT THE BARCODE SYMBOLOGY USED BY THE CUSTOMER WAS CODABAR WITHOUT THE CHECK DIGIT. THE ON-LINE ADVIA 120/2120/2120I OPERATOR GUIDE STATES "BECAUSE OUR RESEARCH INDICATES THAT THE CODABAR SYMBOLOGY PRESENTS AN UNACCEPTABLE POSSIBILITY OF A MISREAD BARCODE LABEL WHEN USED WITH SIEMENS HEMATOLOGY SYSTEMS, WE DO NOT RECOMMEND ITS USE. THE CODABAR SYMBOLOGY SHOULD BE USED ONLY IF YOU CANNOT USE ANY OF THE OTHER SYMBOLOGIES LISTED ABOVE. IF IT IS NOT POSSIBLE TO USE ONE OF THE OTHER SYMBOLOGIES, USE CODABAR WITH A CHECK DIGIT AND WITH BARRIER LINES ON THE TOP AND BOTTOM OF THE BARCODE SYMBOL.". SIEMENS HAS DETERMINED THAT THE CAUSE OF THE EVENT IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. CUSTOMER SERVICE ENGINEER (CSE) VISITED THE CUSTOMER SITE TO DETERMINE THE CAUSE OF THE ADVIA (B)(4) WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT TO MISREAD A SAMPLE TUBE BARCODE. THE CAUSE OF THE EVENT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT SAMPLE TUBE IDENTIFICATION NUMBER (ID) WAS MISREAD BY THE ADVIA (B)(4) WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE RESULTS FROM THE INCORRECTLY IDENTIFIED SAMPLE TUBE WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS AS THE PHYSICIAN DID NOT ORDER A BLOOD TEST FOR THIS PATIENT. THE LABORATORY INVESTIGATED THE ISSUE AND DETERMINED THAT THE INCORRECT SAMPLE ID WAS ASSIGNED TO THE SAMPLE TUBE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT SAMPLE TUBE ID BEING ASSIGNED TO THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847493 ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1