BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS

    MDR report key: 7562719 · Received June 1, 2018

    Report

    Report Number
    2647876-2018-00018
    Event Type
    Death
    Date Received
    June 1, 2018
    Date of Event
    April 26, 2018
    Report Date
    May 30, 2018
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904421946
    PMA / PMN Number
    K954927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INVESTIGATION: BD DIAGNOSTIC SYSTEMS (BDDS) QUALITY INVESTIGATED THE COMPLAINT OF A POTENTIAL FALSE POSITIVE BIOFIRE TEST RESULT WHEN USED WITH BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIAL. THE BIOFIRE BCID IDENTIFIED PROTEUS IN A POSITIVE PATIENT BLOOD CULTURE BOTTLE WITH THE RESULTS BEING REPORTED PRIOR TO THE PATIENT EXPIRING. THE PATIENT WAS A FEW WEEKS IN AGE AND HAD BEEN IN THE NICU FOR AN INFECTION SINCE BIRTH. THE CAREGIVERS WERE AWARE THAT THE PATIENT HAD AN E.COLI INFECTION PRIOR TO RECEIVING THE BIOFIRE RESULTS. THE PATIENT WAS INITIALLY TREATED WITH GENTAMICIN AND THEN GIVEN A STRONGER DOSE AFTER THE POSITIVE BLOOD CULTURE. PROTEUS DID NOT GROW IN CULTURE NOR WAS IT SEEN ON GRAM STAIN. ACCORDING TO THE HOSPITAL THE PATIENT¿S DEATH WAS NOT DUE TO ANY CHANGES IN TREATMENT. BDDS INVESTIGATION FINDINGS TO DATE ARE AS FOLLOWS: WE HAVE TESTED MORE THAN 400 SAMPLES FOR BIOBURDEN AND/OR MOLECULAR TESTING. NO VIABLE PROTEUS ORGANISMS HAVE BEEN RECOVERED IN ANY SAMPLE INCLUDING RAW MATERIALS, IN-PROCESS WATER, THE DEIONIZED (DI) WATER SYSTEM, AND THE ENVIRONMENTAL SAMPLES THROUGHOUT THE MANUFACTURING PROCESS. NO PROTEUS DNA HAS BEEN DETECTED BY MOLECULAR TESTING WITH BIOFIRE FILMARRAY BCID ASSAY IN THE WATER SUPPLY, THE DI WATER SYSTEM AND THE ENVIRONMENTAL SAMPLES THROUGHOUT THE MANUFACTURING PROCESS. CONSISTENT WITH CUSTOMER REPORTS, SOME LOTS OF FINAL PRODUCT TESTED POSITIVE FOR PROTEUS SP WITH BIOFIRE FILMARRAY BCID ASSAY. THERE HAVE BEEN NO RECENT CHANGES TO RAW MATERIALS, DESIGN, MANUFACTURING PROCESS, OR DISTRIBUTION PRACTICES. THE REMAINDER OF BDDS INVESTIGATION WILL FOCUS ON THE FOLLOWING AREAS: ADDITIONAL TESTING OF THE DEHYDRATED MEDIA AND THE RAW MATERIAL COMPONENTS. CROSS-REACTIVITY EVALUATION OF PURIFIED CULTURES OF ENVIRONMENTAL ORGANISMS FOUND DURING BIOBURDEN TESTING. TESTING OF ADDITIONAL IN-PROCESS SAMPLES. FURTHER ACTIONS ARE TO BE DETERMINED BASED ON THE REMAINING INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BIOFIRE IDENTIFIED PROTEUS IN A POSITIVE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIAL WITH RESULTS BEING REPORTED BEFORE THE PATIENT EXPIRED. THE PATIENT WAS A FEW WEEKS IN AGE AND HAD BEEN IN THE NICU FOR THE E. COLI INFECTION SINCE BIRTH. THE CAREGIVERS WERE AWARE THAT THE PATIENT HAD E.COLI PRIOR TO RECEIVING THE BIOFIRE RESULTS. PER THE CUSTOMER, THE PATIENT¿S DEATH WAS NOT DUE TO ANY CHANGES IN TREATMENT AS A RESULT OF THE BIOFIRE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405150 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS CULTURE VIAL MDB BECTON DICKINSON CARIBE LTD. 8015973 00382904421946

    Patients

    Seq Age Sex Outcome Treatment
    1 Death