BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12611220 · Received October 11, 2021

    Report

    Report Number
    2647876-2021-00189
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    August 14, 2021
    Report Date
    February 10, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. AS PER PRODUCT INSERT A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. DUE TO THE NATURE OF BIOLOGICAL MATERIALS IN MEDIA PRODUCTS AND INHERENT ORGANISM VARIABILITY, THE USER SHOULD BE COGNIZANT OF POTENTIAL VARIABLE RESULTS IN THE RECOVERY OF CERTAIN MICROORGANISMS. MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURER¿S INSTRUCTIONS FOR USE. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIAL (PLASTIC) EACH FROM LOTS 1118598 AND 1146363, AND 4 EACH FROM LOT 1160620, PRODUCED MOLECULAR FALSE POSITIVES FOR A. CALCOACETICUS/BAUMANNII ON THE BIOFIRE. GRAM STAINS PRODUCED NEGATIVE RESULTS FOR ACINETOBACTER, BUT GREW AND DETECTED E. COLI, COCCI, AND S. AUREUS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, BUT THERE WAS REPORT OF ONE PATIENT BEING STARTED ON TREATMENT BEFORE DISCONTINUING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FALSE POSITIVE WITH BIOFIRE." "BIOFIRE BCID-2 WAS FLAGGING POSITIVE FOR A. CALCOACETICUS/BAUMANNII COMPLEX, BUT ACINETOBACTER DID NOT GROW. CUSTOMER SAID SOME GRAM STAINS SHOWED GRAM NEGATIVE RODS, BUT E. COLI WAS ALSO DETECTED, AND GREW, AND SOME SHOWED GRAM POSITIVE COCCI, BUT S. AUREUS WAS ALSO DETECTED AND GREW. BCID-2 LOT 1494921, 1415121, AND 1009421. CUSTOMER SAID BACTEC LOTS 1118598, 1146363 AND 1160620 WERE AFFECTED. CUSTOMER ALSO SAID LOT 1140559 WAS AFFECTED, BUT THAT IS NOT SHOWING AS VALID." "1 PATIENT WAS STARTED ON TREATMENT, BUT WAS THEN DISCONTINUED".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1118598. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2021-04-28. MEDICAL DEVICE LOT #: 1146363. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2021-05-26. MEDICAL DEVICE LOT #: 1160620. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2021-06-09. 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 1 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIAL (PLASTIC) EACH FROM LOTS 1118598 AND 1146363, AND 4 EACH FROM LOT 1160620, PRODUCED MOLECULAR FALSE POSITIVES FOR A. CALCOACETICUS/BAUMANNII ON THE BIOFIRE. GRAM STAINS PRODUCED NEGATIVE RESULTS FOR ACINETOBACTER, BUT GREW AND DETECTED E. COLI, COCCI, AND S. AUREUS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, BUT THERE WAS REPORT OF ONE PATIENT BEING STARTED ON TREATMENT BEFORE DISCONTINUING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FALSE POSITIVE WITH BIOFIRE." "BIOFIRE BCID-2 WAS FLAGGING POSITIVE FOR A. CALCOACETICUS/BAUMANNII COMPLEX, BUT ACINETOBACTER DID NOT GROW. CUSTOMER SAID SOME GRAM STAINS SHOWED GRAM NEGATIVE RODS, BUT E. COLI WAS ALSO DETECTED, AND GREW, AND SOME SHOWED GRAM POSITIVE COCCI, BUT S. AUREUS WAS ALSO DETECTED AND GREW. BCID-2 LOT 1494921, 1415121, AND 1009421. CUSTOMER SAID BACTEC LOTS 1118598, 1146363 AND 1160620 WERE AFFECTED. CUSTOMER ALSO SAID LOT 1140559 WAS AFFECTED, BUT THAT IS NOT SHOWING AS VALID." "1 PATIENT WAS STARTED ON TREATMENT, BUT WAS THEN DISCONTINUED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504565 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) BLOOD CULTURING SYSTEM MDB BECTON DICKINSON CARIBE LTD. 442021 SEE SECTION H.10. 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention