BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3863615 · Received June 10, 2014

    Report

    Report Number
    2432235-2014-00367
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    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

    THE INITIAL MDR 2432235-2014-00367 WAS FILED ON JUNE 10, 2014. ADDITIONAL INFORMATION (08/12/2014): SIEMENS HEALTHCARE DIAGNOSTICS, INC. TESTED CALIBRATION OF HEMOGLOBIN A1C ON AN ADVIA CHEMISTRY INSTRUMENT AND WAS UNABLE TO OBTAIN A VALID CALIBRATION WHEN CALIBRATION REAGENT WAS DEPLETED PRIOR TO ASPIRATION OF A STANDARD. THE CAUSE OF THE HEMOGLOBIN A1C CALIBRATION PASSING ON THE ADVIA 1800 INSTRUMENT DESPITE CALIBRATION REAGENT BEING DEPLETED PRIOR TO ASPIRATION OF THE LAST STANDARD IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE HEMOGLOBIN A1C CALIBRATION PASSING ON THE ADVIA 1800 INSTRUMENT DESPITE THE CALIBRATION REAGENT BEING DEPLETED PRIOR TO ASPIRATION OF THE LAST STANDARD IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    THE OPERATOR CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) AFTER A HEMOGLOBIN A1C CALIBRATION ON AN ADVIA 1800 INSTRUMENT PASSED DESPITE THE CALIBRATION REAGENT BEING DEPLETED PRIOR TO ASPIRATION OF THE LAST STANDARD. THE OPERATOR DID NOT RUN QUALITY CONTROLS (QC) OR PATIENT SAMPLES AFTER THIS OCCURRED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HEMOGLOBIN A1C CALIBRATION PASSING DESPITE MISSING ONE STANDARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337851 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1