BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12569428 · Received October 4, 2021

    Report

    Report Number
    2647876-2021-00139
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 3, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-13. 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 TO THE RETENTION SAMPLES IS REQUIRED AT THIS TIME. RETURNED GOOD 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. COMPLAINT IS UNCONFIRMED BASED ON RETENTION AND RETURNED GOOD SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SAMPLES COLLECTED IN THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED FALSE POSITIVE ACINETOBACTER BAUMANII RESULTS ON THE BIOFIRE. THE ACINETOBACTER BAUMANII DID NOT GROW IN CULTURE, BUT THE GRAM STAINS ONLY SHOWED A NEGATIVE RESULTS FOR BACILLUS. THE DOCTOR WAS NOTIFIED OF THE RESULTS, AND THE PATIENT WAS TREATED FOR THE ACINETOBACTER WITH CEFIPIME. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS HAVING ACINETOBACTER BAUMANII COME POSITIVE ON BIOFIRE BUT NOT IN CULTURE FROM BACTEC BOTTLE TYPE 442023, LOT 1160562." "CUSTOMER CALLED TO REPORT 3 BOTTLES THAT CAME POSITIVE FROM THE BACTEC THAT WERE POSITIVE ON THE BIOFIRE FOR ACINETOBACTER BAUMANII BUT IT DID NOT GROW IN CULTURE. TWO BOTTLES WERE FROM TWO AEROBIC BOTTLES FROM DIFFERENT SETS ON THE SAME PATIENT. THE THIRD BOTTLE WAS FROM A DIFFERENT PATIENT. ACINETOBACTER RESULTS WERE REPORTED OUT FOR PATIENT WITH THE TWO BOTTLES THAT WERE POSITIVE ON THE BIOFIRE FOR ACINETOBACTER, BUT THE OTHER PATIENT THE ACINETOBACTER WAS NOT REPORTED OUT." '*WAS ANY ORGANISM SEEN ON THE GRAM STAIN FOR THESE BOTTLES? IF SO WHAT WAS THE ORGANISM REPORTED? YES. GRAM STAIN SHOWED GRAM NEGATIVE BACILLUS. *DID ANY ORGANISM GROW IN CULTURE? CITROBACTER FREUNDII ONLY. THE CITROBACTER ORGANISM ALSO GREW FROM MYCO F LYTIC BOTTLE AS WELL. *WAS THE ACINETOBACTER REPORTED OUT FOR THIS PATIENT? YES. AFTER LOOKING AT CULTURES AND SEEING ONLY CITROBACTER GROWING THE CUSTOMER CALLED DOCTOR TO LET THEM KNOW THEY WERE NOT ABLE TO GROW THE ACINETOBACTER. *WAS THE PATIENT TREATED FOR THE ORGANISM? CUSTOMER UNSURE. CUSTOMER WILL TRY TO FIND OUT IF SEPARATE TREATMENT WAS GIVEN TO CUSTOMER SINCE ENTEROBACTERICIAE WAS ALSO REPORTED OUT AND THEY DON¿T BELIEVE A SEPARATE TREATMENT WOULD HAVE BEEN DONE." "PATIENT #1 WAS TREATED FOR THE ACINETOBACTER, PER THE INFECTION SPECIALIST... THEY TREATED THEM WITH CEFIPIME."

    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 2 SAMPLES COLLECTED IN THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED FALSE POSITIVE ACINETOBACTER BAUMANII RESULTS ON THE BIOFIRE. THE ACINETOBACTER BAUMANII DID NOT GROW IN CULTURE, BUT THE GRAM STAINS ONLY SHOWED A NEGATIVE RESULTS FOR BACILLUS. THE DOCTOR WAS NOTIFIED OF THE RESULTS, AND THE PATIENT WAS TREATED FOR THE ACINETOBACTER WITH CEFIPIME. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS HAVING ACINETOBACTER BAUMANII COME POSITIVE ON BIOFIRE BUT NOT IN CULTURE FROM BACTEC BOTTLE TYPE 442023, LOT 1160562" "CUSTOMER CALLED TO REPORT 3 BOTTLES THAT CAME POSITIVE FROM THE BACTEC THAT WERE POSITIVE ON THE BIOFIRE FOR ACINETOBACTER BAUMANII BUT IT DID NOT GROW IN CULTURE. TWO BOTTLES WERE FROM TWO AEROBIC BOTTLES FROM DIFFERENT SETS ON THE SAME PATIENT. THE THIRD BOTTLE WAS FROM A DIFFERENT PATIENT. ACINETOBACTER RESULTS WERE REPORTED OUT FOR PATIENT WITH THE TWO BOTTLES THAT WERE POSITIVE ON THE BIOFIRE FOR ACINETOBACTER, BUT THE OTHER PATIENT THE ACINETOBACTER WAS NOT REPORTED OUT." WAS ANY ORGANISM SEEN ON THE GRAM STAIN FOR THESE BOTTLES? IF SO WHAT WAS THE ORGANISM REPORTED? YES. GRAM STAIN SHOWED GRAM NEGATIVE BACILLUS. DID ANY ORGANISM GROW IN CULTURE? CITROBACTER FREUNDII ONLY. THE CITROBACTER ORGANISM ALSO GREW FROM MYCO F LYTIC BOTTLE AS WELL. WAS THE ACINETOBACTER REPORTED OUT FOR THIS PATIENT? YES. AFTER LOOKING AT CULTURES AND SEEING ONLY CITROBACTER GROWING THE CUSTOMER CALLED DOCTOR TO LET THEM KNOW THEY WERE NOT ABLE TO GROW THE ACINETOBACTER. WAS THE PATIENT TREATED FOR THE ORGANISM? CUSTOMER UNSURE. CUSTOMER WILL TRY TO FIND OUT IF SEPARATE TREATMENT WAS GIVEN TO CUSTOMER SINCE ENTEROBACTERICIAE WAS ALSO REPORTED OUT AND THEY DON¿T BELIEVE A SEPARATE TREATMENT WOULD HAVE BEEN DONE." "PATIENT WAS TREATED FOR THE ACINETOBACTER, PER THE INFECTION SPECIALIST... THEY TREATED THEM WITH CEFIPIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470567 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 Unknown Required Intervention