BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120 WITH AUTOSAMPLER

    MDR report key: 4502274 · Received February 10, 2015

    Report

    Report Number
    2432235-2015-00064
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 29, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) US BRANCH HAS REQUESTED PATIENT AND QUALITY CONTROL DATA FROM THE CUSTOMER REGARDING THE ERRONEOUS WHITE BLOOD CELL (WBC) COUNT REPORTED ON THE ADVIA 120 WITH AUTOSAMPLER SYSTEM. THE US BRANCH HAS INDICATED THAT NO ADDITIONAL INFORMATION WILL BE FORTHCOMING AS THE CUSTOMER HAS ASKED SIEMENS TO DISREGARD THE INFORMATION AND THAT THEY WOULD HANDLE THE ISSUE INTERNALLY. THE CAUSE OF THE ERRONEOUS WBC COUNT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS AND REPORTED THAT THE ADVIA 120 WITH AUTOSAMPLER SYSTEM REPORTED AN ERRONEOUS WHITE BLOOD CELL (WBC) COUNT. NO PATIENT DATA WAS PROVIDED BY THE CUSTOMER. THE ERRONEOUS WBC WAS REPORTED TO THE PHYSICIAN AND IT IS UNKNOWN IF THE PHYSICIAN QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPEATED ON AN ADVIA 2120I SYSTEM FOR COMPARISON AND VIA FLOW CYTOMETRY. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS WBC COUNT REPORTED BY THE ADVIA 120 WITH AUTOSAMPLER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94070 ADVIA 120 WITH AUTOSAMPLER ADVIA 120 WITH AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA 120 WITH AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1