BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT

    MDR report key: 5057461 · Received September 4, 2015

    Report

    Report Number
    2432235-2015-00386
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JFM
    PMA / PMN Number
    K063845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 CUSTOMER INFORMED CCC THAT THEY WERE AWARE OF THIS CLAIM. 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 DISCORDANT RESULT AND THE INFANT WAS HOSPITALIZED. AFTER ADMISSION TO THE HOSPITAL THE TEST WAS REPEATED AGAIN ON THE PATIENT (NEW BLOOD DRAW) AND WAS WITHIN THE EXPECTED RANGE. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS ACCEPTABLE. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT FOR TOTAL BILIRUBIN ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587334 ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT JFM SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT 327280

    Patients

    Seq Age Sex Outcome Treatment
    1