BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR

    MDR report key: 4205775 · Received October 28, 2014

    Report

    Report Number
    2432235-2014-00617
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Date of Event
    September 10, 2014
    Report Date
    May 3, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIX
    PMA / PMN Number
    K081895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) REPRESENTATIVE HAS EVALUATED THE PATIENT DATA. THE CAUSE OF THE INITIAL LOW RESULT FOR A1C3 WHEN USING CALIBRATOR LOT 3DD010 IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00617 WAS FILED ON OCTOBER 28, 2014. ADDITIONAL INFORMATION (2/12/2015): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) EVALUATED THE DATA PROVIDED BY THE CUSTOMER. HSC IDENTIFIED INCIDENCES OF CLOTTED SAMPLES BEING RUN ON THE INSTRUMENT. THE CUSTOMER WAS NOT FOLLOWING MANUFACTURER'S INSTRUCTIONS ON SAMPLE HANDLING. THE CAUSE OF THE INITIAL HIGH RESULTS FOR A1C_3 IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBTAINED A LOWER VALUE FOR A1C3 ON ONE PATIENT SAMPLE ON AN ADVIA 2400 INSTRUMENT WHEN USING CALIBRATOR LOT 3DD010. THE SAMPLE WAS TESTED ON SEPTEMBER 10, 2014 FOR A1C3 ON THE ADVIA 2400. THE PATIENT WENT TO ANOTHER FACILITY AND GOT THEMSELVES TESTED ON AN ALTERNATE PLATFORM AND THE RESULT WAS HIGHER. THREE DAYS AFTER THE EVALUATION THE PATIENT HAD TO BE HOSPITALIZED DUE TO ACUTE SIGNS OF HYPERGLYCEMIA. IT IS UNKNOWN IF THE INITIAL RESULT ON THE ADVIA 2400 OR THE RESULT ON THE ALTERNATE PLATFORM WERE REPORTED TO PHYSICIAN(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO INITIAL LOW RESULT FOR A1C3 ON THE ONE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689993 ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR JIX SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY A1C_3 CALIBRATOR 3DD010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR