BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH AUTOSAMPLER

    MDR report key: 2576542 · Received May 16, 2012

    Report

    Report Number
    2432235-2012-00155
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATING THE INSTRUMENT, THE FSE FOUND THAT THE POWER TO THE HEMOGLOBIN LAMP WAS LOW. THE FSE ADJUSTED THE LAMP'S BASELINE READING TO 3.9, AND RAN QC MATERIAL AND OBTAINED ACCEPTABLE RESULTS. THE FSE ALSO RAN PATIENT SAMPLES (IN TRIPLICATE) USING THE AUTO-SAMPLER MODE AND COMPARED THE HGB AND HCT RESULTS TO THOSE GENERATED ON ANOTHER HEMATOLOGY ANALYZER. THE HGB AND HCT RESULTS WERE CONSISTENT AMONG THE 3 REPLICATES AND MATCHED THOSE FROM THE OTHER ANALYZER. THE CAUSE OF THE DISCORDANT LOW HGB AND HCT RESULTS IS UNKNOWN. NO CONCLUSIONS CAN BE DRAWN AS TO WHAT SPECIFICALLY CAUSED THE DISCORDANT HGB AND HCT RESULTS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE INSTRUMENT IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS WERE OBTAINED WITH ONE (1) PATIENT SAMPLE TESTED ON AN ADVIA 2120 ANALYZER USING THE AUTO-SAMPLER MODE. THE INITIAL DISCORDANT LOW HGB AND HCT RESULTS WERE REPORTED TO THE PHYSICIAN. THE LOW RESULTS WERE QUESTIONED DUE TO THE PATIENT'S HISTORY, AND THE SAMPLE WAS RETESTED ON THE SAME ANALYZER, ALSO USING THE AUTO-SAMPLER MODE. A NEW SAMPLE WAS DRAWN FROM THE PATIENT, AND HGB AND HCT WERE RUN USING THE MANUAL OPEN-TUBE SAMPLER MODE. A CORRECTED REPORT WITH THE RESULTS FROM THE NEW SAMPLE WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED, DELAYED, OR WITHHELD DUE TO THE DISCORDANT LOW HGB AND HCT RESULTS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HGB AND HCT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 WITH AUTOSAMPLER HEMATOLOGY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120

    Patients

    Seq Age Sex Outcome Treatment
    1