BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD MAX MRSA ASSAY

    MDR report key: 4569664 · Received February 23, 2015

    Report

    Report Number
    MW5041071
    Event Type
    Death
    Date Received
    February 23, 2015
    Date of Event
    February 21, 2015
    Report Date
    February 23, 2015
    Manufacturer
    BD
    Product Code
    NQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUR INSTITUTION USES A BD MAX MRSA ASSAY FOR NASAL SWAB SPECIMENS AND POSITIVE BLOOD CULTURES WITH GRAM POSITIVE COCCI IN CLUSTERS. PT WAS ADMITTED FOR A LOW HEMOGLOBIN ON (B)(6). PT WAS EVENTUALLY FOUND TO HAVE A HEMOTHORAX AND TRANSFERRED TO THE ICU ON (B)(6). PT SPIKED FEVERS ON (B)(6) AND BLOOD CULTURES WERE OBTAINED THAT TURNED POSITIVE LATER THAT DAY. GRAM STAIN OF BLOOD CULTURE SHOWED GRAM POSITIVE COCCI IN CLUSTERS. THE SPECIMEN WAS RUN ON THE BD MAX (B)(4) ASSAY. THE ASSAY SUGGESTED (B)(6). THE ICU TEAM SWITCHED THE PT FROM VANCOMYCIN TO NAFCILLIN. TRADITIONAL CULTURE AND SENSITIVITY LATER REVEALED (B)(6). THE PT IS NOW UNDER HOSPICE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127263 BD MAX MRSA ASSAY BD MAX MRSA ASSAY NQX BD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death