BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12652346 · Received October 18, 2021

    Report

    Report Number
    2647876-2021-00219
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 13, 2021
    Report Date
    November 16, 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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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. BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO ADDITIONAL TESTING IS REQUIRED AT THIS TIME. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING ON BIOFIRE WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE FOR ACINETOBACTER WAS OBTAINED. CONFIRMATORY CULTURE WAS PERFORMED AND THERE WAS NO GROWTH. CUSTOMER HAS NOT CONFIRMED IF TREATMENT FOR ACINETOBACTER WAS PROVIDED TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT 2 OF 7 IT WAS REPORTED THAT ACINETOBACTER RESULTING ON BIOFIRE FOR POSITIVE 442023 BOTTLES LOT 1160562, BUT IT DOES NOT GROW IN CULTURE. PLEASE PROVIDE THE DATE THIS PATIENT WAS TESTED ON THE BIOFIRE: (B)(6) 2021. WAS BIOFIRE RESULT DUAL POSITIVE? YES. ACINETOBACTER AND STAPH SPECIES WAS ANY ORGANISM SEEN ON THE GRAM STAIN FOR THIS BOTTLE? YES IF SO WHAT WAS THE ORGANISM REPORTED? GRAM POSITIVE COCCI IN CLUSTERS AND GRAM NEGATIVE COCCI DID ANY ORGANISM GROW IN CULTURE? STAPHYLOCOCCUS HOMINUS. WAS THE ACINETOBACTER REPORTED OUT FOR THIS PATIENT? YES. WAS THE PATIENT TREATED FOR THE ACINTOBACTER? CUSTOMER UNSURE BUT WILL FOLLOW UP AFTER SPEAKING WITH THE PHARMACY. IF SO WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? PENDING FOLLOW UP WITH CUSTOMER. CAN YOU PROVIDE THE SERIAL NUMBER OF THE BACTEC THE BOTTLE WAS IN WHEN IT WENT POSITIVE? PENDING FOLLOW UP WITH CUSTOMER AS INFORMATION WAS NOT AVAILABLE ON CALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING ON BIOFIRE WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE FOR ACINETOBACTER WAS OBTAINED. CONFIRMATORY CULTURE WAS PERFORMED AND THERE WAS NO GROWTH. CUSTOMER HAS NOT CONFIRMED IF TREATMENT FOR ACINETOBACTER WAS PROVIDED TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT 2 OF 7. IT WAS REPORTED THAT ACINETOBACTER RESULTING ON BIOFIRE FOR POSITIVE 442023 BOTTLES LOT 1160562, BUT IT DOES NOT GROW IN CULTURE. PLEASE PROVIDE THE DATE THIS PATIENT WAS TESTED ON THE BIOFIRE: (B)(6) 2021. WAS BIOFIRE RESULT DUAL POSITIVE? YES. ACINETOBACTER AND STAPH SPECIES. WAS ANY ORGANISM SEEN ON THE GRAM STAIN FOR THIS BOTTLE? YES. IF SO WHAT WAS THE ORGANISM REPORTED? GRAM POSITIVE COCCI IN CLUSTERS AND GRAM NEGATIVE COCCI. DID ANY ORGANISM GROW IN CULTURE? STAPHYLOCOCCUS HOMINOUS. WAS THE ACINETOBACTER REPORTED OUT FOR THIS PATIENT? YES. WAS THE PATIENT TREATED FOR THE ACINETOBACTER? CUSTOMER UNSURE BUT WILL FOLLOW UP AFTER SPEAKING WITH THE PHARMACY. IF SO WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? PENDING FOLLOW UP WITH CUSTOMER. CAN YOU PROVIDE THE SERIAL NUMBER OF THE BACTEC THE BOTTLE WAS IN WHEN IT WENT POSITIVE? PENDING FOLLOW UP WITH CUSTOMER AS INFORMATION WAS NOT AVAILABLE ON CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546292 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1160562 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown