BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 4708067 · Received April 20, 2015

    Report

    Report Number
    2432235-2015-00181
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) TECHNICAL SUPPORT TECHNICIAN INFORMED THE CUSTOMER THAT THEY WERE NOT OPERATING THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT IN A CONFIGURATION RECOMMENDED BY SIEMENS. THE CAUSE OF THE EVENT IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SUPPORT TECHNICIAN REPORTED THAT THE CUSTOMER WAS OPERATING THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT BY BY-PASSING THE SELECTOR VALVE AND RUNNING PATIENT SAMPLES STRAIGHT INTO THE SHEAR VALVE. IT IS UNKNOWN IF THE CLOT FILTER WAS IN PLACE WHEN THE SELECTOR VALVE WAS BY-PASSED. THIS WAS HAPPENING ON THE NIGH SHIFT ONLY TO REDUCE THE NUMBER OF ASPIRATION FAILURES. THEY REVERTED THE SYSTEM BACK TO THE RECOMMENDED CONFIGURATION FOR THE DAY SHIFT. QUALITY CONTROL MATERIAL WAS ALWAYS WITHIN SPECIFICATIONS. PATIENT RESULTS WERE REPORTED TO PHYSICIANS, WHO HAVE NOT QUESTIONED ANY OF THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER BY-PASSING THE SELECTOR VALVE ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261596 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