BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3241399 · Received July 22, 2013

    Report

    Report Number
    2432235-2013-00323
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND RESTRICTIONS IN THE SALINE SUPPLY TUBE, CUVETTE WASH AND CUVETTE CONDITIONER LINES AS WELL AS A LOW VOLTAGE LAMP. THE FSE REPLACED THE LAMP AND REMOVED RESTRICTIONS FROM TUBINGS. LAMP ENERGY, CELLBLANK , CALIBRATION AND QUALITY CONTROLS WERE RUN AND ALL WAS WITHIN SPECIFICATION. THE CAUSE OF CALCIUM IMPRECISION WAS RESTRICTIONS IN THE TUBING AND A LOW VOLTAGE LAMP. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WAS RUN ON AN ADVIA 1800 INSTRUMENT THREE TIMES, AND THE RESULTS WERE INCONSISTENT. THE SAMPLE RESULTED LOWER EACH TIME IT WAS REPEATED. NO RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCONSISTENT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341511 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1