BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPERT MRSA/SA BC

    MDR report key: 7380500 · Received March 28, 2018

    Report

    Report Number
    3004530258-2018-00001
    Event Type
    Death
    Date Received
    March 28, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 28, 2018
    Manufacturer
    CEPHEID
    Product Code
    NQX
    UDI-DI
    07332940000141
    PMA / PMN Number
    K101879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OR ALLEGATION FROM THE FIELD/CLINIC THAT THE DEVICE CONTRIBUTED TO THE INCIDENT. (B)(6) INVESTIGATION HAS DETERMINED THAT THIS IS NOT A DEVICE MALFUNCTION, PRODUCT IS ADEQUATELY LABELED AND THE PRODUCT HAS PERFORMED ACCORDING TO PRODUCT CLAIMS. (B)(4).

    Description of Event or Problem · 1

    THIS CASE CONCERNED A DISCREPANCY BETWEEN (B)(6) RESULTS, WHICH WERE INITIALLY REPORTED (B)(6) / (B)(6) ON (B)(6) 2018. THE FOLLOWING DAY ((B)(6) 2018), (B)(6) GREW IN CULTURE AND WAS CONFIRMED AS (B)(6) BY MICROSCAN AND DISK DIFFUSION. THE BLOOD CULTURE BOTTLE WAS RETESTED AND WAS DETERMINED TO BE (B)(6) BY (B)(6) (LIKELY A MUTATION WITHIN (B)(6) TARGETS PROBE OR BINDING SITES). ACCORDING TO THE LAB, THERE WAS A DELAY IN REPORTING (B)(6) BY APPROXIMATELY 24 HOURS AND DURING THIS TIME THE PATIENT WAS NOT ON (B)(6) ACTIVE DRUGS. PATIENT WAS A (B)(6) YEAR OLD MALE FROM A NURSING HOME ADMITTED FOR SEPSIS. PATIENT DIED ON (B)(6) 2018, ALTHOUGH HIS ANTIBIOTIC THERAPY HAD BEEN CHANGED TO THREE DRUGS TO WHICH THE (B)(6) ORGANISM WAS SUSCEPTIBLE. THE DISCREPANT RESULT MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. A FOLLOW-UP BLOOD CULTURE USING (B)(6) REPORTED (B)(6) (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219918 XPERT MRSA/SA BC GXMRSA/SA-BC-10 NQX CEPHEID XPERT MRSA/SA BC 1000078626 07332940000141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death