BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 5708454 · Received June 9, 2016

    Report

    Report Number
    2432235-2016-00308
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 6, 2016
    Report Date
    July 20, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE BARCODE MISREAD.

    Additional Manufacturer Narrative · 1

    INITIAL MDR 2432235-2016-00308 WAS FILED ON JUNE 9, 2016. ADDITIONAL INFORMATION (7/14/2016): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) REVIEWED DATA PROVIDED BY THE CUSTOMER REGARDING THE BARCODE ERROR ON THIS SPECIFIC PATIENT SAMPLE. HSC COULD NOT CONFIRM THE CUSTOMERS OBSERVATIONS BASED ON THE DATA PROVIDED. HSC INFORMED THE CUSTOMER THAT DEBUG LOGS PROVIDE DETAILED INFORMATION REGARDING THE COMMUNICATION BETWEEN THE ANALYZER AND THE DATA MANAGER. HSC CONFIRMED THAT THESE LOGS WERE NOT ACTIVATED AT THE TIME OF THIS INCIDENT. THE CUSTOMER HAS BEEN NOTIFIED TO ACTIVATE THE DEBUG LOGS GOING FORWARD. THE INCORRECT BARCODE ERROR COULD NOT BE CONFIRMED BY HSC AND THE CAUSE IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT SAMPLE WITH BAR CODE ID (B)(6) WAS PROCESSED ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ANALYZER AND AWAITED RELEASE IN THE LIS. ANOTHER PATIENT SAMPLE (BAR CODE (B)(6)) WAS ALSO PROCESSED ON THE SAME ANALYZER AND WAS READ AS BARCODE ID (B)(6). THE RESULT FROM BAR CODE ID (B)(6) REPLACED THE RESULT FOR BARCODE ID (B)(6) AND WAS REPORTED TO THE PHYSICIAN(S) FOR THE PATIENT WITH BARCODE ID (B)(6). PATIENT SAMPLE BARCODE ID (B)(6) WAS RE-RUN ON THE ANOTHER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ANALYZER AND A CORRECTED RESULT WAS GENERATED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367776 ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1