BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12537442 · Received September 27, 2021

    Report

    Report Number
    2647876-2021-00130
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 31, 2021
    Report Date
    November 10, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX WERE OBTAINED FROM THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC). THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT IN THE LAST TWO WEEKS THE CUSTOMER HAS HAD 4 POSITIVE BLOOD CULTURES ON LOT 1160620 EXP 3/31/22 THAT SHOW ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX ON BCID2 BIOFIRE PANELS." "CUSTOMER STATED THAT WAS NO PATIENT IMPACTS."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX WERE OBTAINED FROM THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC). THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT IN THE LAST TWO WEEKS THE CUSTOMER HAS HAD 4 POSITIVE BLOOD CULTURES ON LOT 1160620 EXP 3/31/22 THAT SHOW ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX ON BCID2 BIOFIRE PANELS." "CUSTOMER STATED THAT WAS NO PATIENT IMPACTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430165 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) BLOOD CULTURING SYSTEM MDB BECTON DICKINSON CARIBE LTD. 442021 1160620 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown