BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY XPT HEMOGLOBIN A1C_3 CALIBRATOR

    MDR report key: 5011639 · Received August 18, 2015

    Report

    Report Number
    2432235-2015-00367
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 24, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIX
    PMA / PMN Number
    K081895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL ASSAY SPECIALIST (TAS) WAS NOTIFIED BY THE CUSTOMER THAT THEY WERE INCORRECTLY USING THE HEMOGLOBIN A1C_3 ASSAY ON THE ADVIA CHEMISTRY XPT INSTRUMENT AND NOT FOLLOWING THE INSTRUCTINS FOR USE (IFU) PROVIDED WITH THE ASSAY. THE HEMOGLOBIN A1C_3 ASSAY IFU DOES NOT ASK FOR SAMPLES TO BE PREDILUTED PRIOR TO RUNNING ON THE INSTRUMENT. SIEMENS TAS WAS ALSO INFORMED THAT THE CUSTOMER HAS BEEN USING THE METHOD AND IS AWARE OF THE IFU AND TO NOT CONTACT THE CUSTOMER FOR PATIENT DATA. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER IS INCORRECTLY DILUTING PATIENT SAMPLES FOR HEMOGLOBIN A1C_3 PRIOR TO TESTING ON AN ADVIA CHEMISTRY XPT INSTRUMENT. SAMPLES WITH VALUES GREATER THAN 6% FOR HEMOGLOBIN A1C_3 ARE BEING DILUTED 30% PRIOR TO BEING RUN ON THE ADVIA CHEMISTRY XPT INSTRUMENT. IT IS UNKNOWN IF PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE POSSIBLE DISCORDANT RESULTS FOR HEMOGLOBIN A1C_3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544797 ADVIA CHEMISTRY XPT HEMOGLOBIN A1C_3 CALIBRATOR ADVIA CHEMISTRY XPT HEMOGLOBIN A1C_3 CALIBRATOR JIX SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT HEMOGLOBIN A1C_3 CALIBRATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1