BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12569408 · Received October 4, 2021

    Report

    Report Number
    2647876-2021-00140
    Event Type
    Malfunction
    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
    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 THE SAMPLE COLLECTED IN THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL (PLASTIC) PRODUCED A FALSE POSITIVE ACINETOBACTER BAUMANII RESULT ON THE BIOFIRE. THE ACINETOBACTER BAUMANII DID NOT GROW IN CULTURE, AND GRAM STAINS WERE ALSO NEGATIVE. THE DOCTOR WAS NOT NOTIFIED OF THE ERRONEOUS RESULTS, AND THE PATIENT WAS ONLY TREATED FOR STAPHYLOCOCCUS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND 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." "*WHAT WAS SEEN ON THE GRAM STAIN? GRAM POSITIVE COCCI ONLY. *WHAT ORGANISM GREW IN CULTURE? STAPHYLOCOCCUS ON. ACIENTOBACTER DID NOT GROW *WAS THE ACINETOBACTER REPORTED OUT FOR THE PATIENT? YES. AFTER NO GROWTH OF THE ORGANISM ON CULTURE PLATES THEY WENT BACK AND NOTED THE ORGANISM NOT VIABLE. *IF THE ACINETOBACTER WAS REPORTED OUT WAS THE PATIENT TREATED FOR THIS ORGANISM? WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? CUSTOMER IS UNSURE BUT THEY ARE REACHING OUT TO PROVIDER FOR MORE INFORMATION" "PATIENT TWO WAS NOT TREATED FOR THE ACINETOBACTER, PER THE NP IN THE ED AT THE TIME. THEY WERE TREATED FOR THE STAPHYLOCOCCUS ONLY. SHE ALSO NOTED THAT HAD THEY WANTED TO TREAT FOR THE ACINETOBACTER, THEY PROBABLY WOULD HAVE USED THE SAME DRUG AS FOR THE STAPHYLOCOCCUS ANYWAY."

    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 THE SAMPLE COLLECTED IN THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL (PLASTIC) PRODUCED A FALSE POSITIVE ACINETOBACTER BAUMANII RESULT ON THE BIOFIRE. THE ACINETOBACTER BAUMANII DID NOT GROW IN CULTURE, AND GRAM STAINS WERE ALSO NEGATIVE. THE DOCTOR WAS NOT NOTIFIED OF THE ERRONEOUS RESULTS, AND THE PATIENT WAS ONLY TREATED FOR STAPHYLOCOCCUS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND 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." "WHAT WAS SEEN ON THE GRAM STAIN? GRAM POSITIVE COCCI ONLY. WHAT ORGANISM GREW IN CULTURE? STAPHYLOCOCCUS ON. ACIENTOBACTER DID NOT GROW WAS THE ACINETOBACTER REPORTED OUT FOR THE PATIENT? YES. AFTER NO GROWTH OF THE ORGANISM ON CULTURE PLATES THEY WENT BACK AND NOTED THE ORGANISM NOT VIABLE. IF THE ACINETOBACTER WAS REPORTED OUT WAS THE PATIENT TREATED FOR THIS ORGANISM? WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? CUSTOMER IS UNSURE BUT THEY ARE REACHING OUT TO PROVIDER FOR MORE INFORMATION" "PATIENT TWO WAS NOT TREATED FOR THE ACINETOBACTER, PER THE NP IN THE ED AT THE TIME. THEY WERE TREATED FOR THE STAPHYLOCOCCUS ONLY. SHE ALSO NOTED THAT HAD THEY WANTED TO TREAT FOR THE ACINETOBACTER, THEY PROBABLY WOULD HAVE USED THE SAME DRUG AS FOR THE STAPHYLOCOCCUS ANYWAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469976 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