BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 4243546 · Received November 11, 2014

    Report

    Report Number
    2432235-2014-00623
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 5, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS' (SIEMENS) REGIONAL APPLICATION SPECIALIST SUBMITTED THE COMPLAINT REGARDING AN ERRONEOUS BARCODE READ ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE EVENT IS DUE TO THE CUSTOMER USING CODABAR BARCODE SYMBOLOGY WITHOUT A CHECK DIGIT. AS PER THE ADVIA 2120 ON-LINE HELP, SIEMENS DOES NOT RECOMMEND THE USE OF CODABAR. HOWEVER, IF THE CUSTOMER CANNOT USE ANY OF THE RECOMMENDED BARCODE SYMBOLOGIES, SIEMENS RECOMMENDS THAT THEY USE CODABAR WITH THE CHECK DIGIT ACTIVE AND WITH BARRIER LINES ON THE TOP AND BOTTOM OF THE BARCODE SYMBOL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    PATIENT SAMPLE IDENTIFICATION (SID) NUMBER (B)(6) WAS MISREAD AS (B)(6) ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER WHEN SAMPLED IN THE AUTOSAMPLER MODE. THE LAB DID NOT HAVE ANY HEMATOLOGY TESTS ORDERED FOR SID (B)(6). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT SID BEING ASSOCIATED WITH THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727743 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