BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT

    MDR report key: 5038961 · Received August 28, 2015

    Report

    Report Number
    2432235-2015-00380
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 12, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JFM
    PMA / PMN Number
    K063845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS CUSTOMER CARE CENTER (CCC) HAS NOTIFIED THE CUSTOMER THAT THE ADVIA CHEMISTRY TOTAL BILIRUBIN_2 ASSAY HAS NOT BEEN VALIDATED WITH NEONATAL SAMPLES AND IS NOT APPROVED BY THE FDA FOR TESTING WITH NEONATAL SAMPLES. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER IS RUNNING NEONATAL SAMPLES FOR TOTAL BILIRUBIN_2 (TBIL_2) ON AN ADVIA CHEMISTRY 1800 INSTRUMENT. A NEONATAL SAMPLE RUN ON THE ADVIA CHEMISTRY 1800 INSTRUMENT GAVE A HIGH RESULT. AS PER THE LABORATORY'S PROTOCOL ALL HIGH SAMPLES ARE TESTED ON AN ALTERNATE PLATFORM. THE RESULT ON THE ALTERNATE PLATFORM WAS LOWER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGHER RESULT FOR TOTAL BILIRUBIN ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572881 ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT JFM SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT 347801

    Patients

    Seq Age Sex Outcome Treatment
    1