BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17731108 · Received September 12, 2023

    Report

    Report Number
    2647876-2023-00126
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    September 4, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.7 INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 11-SEP-2023. H3. INVESTIGATION SUMMARY: CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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/RETURNED 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO TREND IDENTIFIED FOR BATCH. COMPLAINT IS UNCONFIRMED BASED ON RETENTION/RETURNED 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. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT 2 OF 2. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT # 1: (B)(6) 2023, LOT #: 3102666, SEQUENCE # (B)(6) GRAM STAIN WAS "NO ORGANISMS SEEN" BIOFIRE DETECTED C. TROPICALIS ONLY BOTTLE WAS PLACED BACK ON THE INSTRUMENT AND DEEMED A FALSE POSITIVE. BOTTLE WAS FLAGGED POSITIVE AGAIN A FEW HOURS LATER, GRAM STAIN WAS NOS, AND THE BIOFIRE RESULTS HAD NO ORGANISMS DETECTED. CUSTOMER PLACED BOTTLE IN INCUBATOR FOR MANUAL INCUBATION AND DID A BLIND SUB AND GRAM STAIN ON DAY 3. FOUND GRAM POSITIVE COCCI IN CLUSTERS ON THE GRAM STAIN. PATIENT # 2: (B)(6) 2023, LOT #: 3102666, SEQUENCE #: (B)(6) GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS BIOFIRE WAS A DUAL POSITIVE - STAPH SPP. AND C. TROPICALIS CULTURE GREW STAPH SACCHAROLYTICUS NO RESULTS WERE REPORTED CONFIRMATORY TESTING WAS CULTURE. TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 3 BOTTLES WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 2 MOLECULAR FPS.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT 2 OF 2. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT # 1: (B)(6) 2023, LOT #: 3102666, SEQUENCE # 446589598390. GRAM STAIN WAS "NO ORGANISMS SEEN." BIOFIRE DETECTED C. TROPICALIS ONLY. BOTTLE WAS PLACED BACK ON THE INSTRUMENT AND DEEMED A FALSE POSITIVE. BOTTLE WAS FLAGGED POSITIVE AGAIN A FEW HOURS LATER, GRAM STAIN WAS NOS, AND THE BIOFIRE RESULTS HAD NO ORGANISMS DETECTED. CUSTOMER PLACED BOTTLE IN INCUBATOR FOR MANUAL INCUBATION AND DID A BLIND SUB AND GRAM STAIN ON DAY 3. FOUND GRAM POSITIVE COCCI IN CLUSTERS ON THE GRAM STAIN. PATIENT # 2: (B)(6) 2023, LOT #: 3102666, SEQUENCE #: 446589598452. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. BIOFIRE WAS A DUAL POSITIVE - STAPH SPP. AND C. TROPICALIS. CULTURE GREW STAPH SACCHAROLYTICUS. NO RESULTS WERE REPORTED. CONFIRMATORY TESTING WAS CULTURE. TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 3 BOTTLES. WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 2 MOLECULAR FPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173825 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3102666 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown