BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12599012 · Received October 8, 2021

    Report

    Report Number
    2647876-2021-00181
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 5, 2021
    Report Date
    October 25, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CATALOG: 442021. BATCH NO: 1160620. 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. 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. REFER TO CUSTOMER LETTER BD-43184. 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. CATALOG: 442021. BATCH NO.:1167215. 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. REFER TO CUSTOMER LETTER BD-43184. 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 H.10

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1160620, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2021-06-09. MEDICAL DEVICE LOT #: 1167215, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2021-06-16. 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 7 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) EACH FROM LOTS 1160620 AND 1167215 PRODUCED MOLECULAR FALSE POSITIVE RESULTS FOR ACINETOBACTER ON THE BIOFIRE INSTRUMENT. SUBCULTURE CONFIRMATORY TESTING WAS PERFORMED WITH ALL RESULTS COMING BACK NEGATIVE. ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIANS, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING MOLECULAR FALSE POSITIVES WITH USE OF BIOFIRE INSTRUMENTATION AND BACTEC VIALS 442021 LOTS 1167215 AND 1160620.". "NONVIABLE ACINETOBACTER WAS DETECTED USING THE BIOFIRE.". "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? UNKNOWN. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? UNKNOWN". "WERE VIALS ALSO SUBCULTURED? YES. WAS ACINETOBACTER FOUND TO BE NONVIABLE IN EVERY CASE? YES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) EACH FROM LOTS 1160620 AND 1167215 PRODUCED MOLECULAR FALSE POSITIVE RESULTS FOR ACINETOBACTER ON THE BIOFIRE INSTRUMENT. SUBCULTURE CONFIRMATORY TESTING WAS PERFORMED WITH ALL RESULTS COMING BACK NEGATIVE. ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIANS, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING MOLECULAR FALSE POSITIVES WITH USE OF BIOFIRE INSTRUMENTATION AND BACTEC VIALS 442021 LOTS 1167215 AND 1160620." "NONVIABLE ACINETOBACTER WAS DETECTED USING THE BIOFIRE." "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? UNKNOWN. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? UNKNOWN". "WERE VIALS ALSO SUBCULTURED? YES. WAS ACINETOBACTER FOUND TO BE NONVIABLE IN EVERY CASE? YES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493514 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