BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12652295 · Received October 18, 2021

    Report

    Report Number
    2647876-2021-00218
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 16, 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

    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.

    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. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT 3 OF 7 IT WAS REPORTED THAT ACINETOBACTER RESULTING ON BIOFIRE FOR POSITIVE 442023 BOTTLES LOT 1160562, BUT IT DOES NOT GROW IN CULTURE. WAS THE PATIENT TREATED FOR THE ACINETOBACTER? NO. IF SO WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? NO.

    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. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT 3 OF 7. IT WAS REPORTED THAT ACINETOBACTER RESULTING ON BIOFIRE FOR POSITIVE 442023 BOTTLES LOT 1160562, BUT IT DOES NOT GROW IN CULTURE. *WAS THE PATIENT TREATED FOR THE ACINETOBACTER? NO. *IF SO WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546085 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