BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12579063 · Received October 5, 2021

    Report

    Report Number
    2647876-2021-00144
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. AS PER PRODUCT INSERT A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. DUE TO THE NATURE OF BIOLOGICAL MATERIALS IN MEDIA PRODUCTS AND INHERENT ORGANISM VARIABILITY, THE USER SHOULD BE COGNIZANT OF POTENTIAL VARIABLE RESULTS IN THE RECOVERY OF CERTAIN MICROORGANISMS. MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURER¿S INSTRUCTIONS FOR USE. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS MOLECULAR CONTAMINATION WITH ACINETOBACTER CALCOACETICUS-BAUMANII WHEN RUNNING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) ON THE BIOFIRE. CONFIRMATORY TESTING WITH GRAM STAINS HAD NEGATIVE RESULTS, AND SUBCULTURES ONLY SHOWED PROTEUS SPP GROWTH. THE RESULTS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING MOLECULAR CONTAMINATION WITH ACINETOBACTER CALCOACETICUS-BAUMANII WHEN RUNNING POSITIVE BACTEC 442023 BOTTLE, LOT 1160562" "CUSTOMER HAS (B)(4) OPENED TO ORIGINALLY REPORT OUT TWO BOTTLES OF 442023, LOT 1160562 THAT CAME UP WITH ACINETOBACTER CALCOACETICUS-BAUMANII ON THE BIOFIRE. THE CUSTOMER WILL LOOK AT SUBCULTURES BEFORE REPORTING OUT ORGANISM. 4 BOTTLES FROM THE PATIENT WENT POSITIVE. CUSTOMER RAN ANAEROBIC BOTTLE AND IT CAME BACK AS E.COLI ON BIOFIRE. THEY RAN THE AEROBIC 442023 BOTTLE FROM LOT 1160562 AND IT WAS E.COLI AND ACINETOBACTER." "*WHAT WAS SEEN IN GRAM STAIN? GRAM NEGATIVE BACILLUS *WAS THE ACINETOBACTER REPORTED OUT FOR THE PATIENT? NO. WAITING TO COMPARE WITH CULTURE RESULTS FIRST. CUSTOMER HAS SUBBED TO BLOOD, CHOCOLATE AND MAC AGAR PLATES" "THEY DID NOT REPORT OUT THE ACINETOBACTER ON THE BCID2, SO THE PATIENT WOULD NOT HAVE BEEN TREATED FOR IT. UPON EXAMINING THE SUBCULTURE, IT APPEARS ONLY A PROTEUS SPP GREW OUT (CONSISTENT WITH THE REST OF THE BCID2 RESULTS.)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472342 BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BLOOD CULTURING SYSTEM MDB BECTON DICKINSON CARIBE LTD. 442023 1160562 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1