BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18107378 · Received November 9, 2023

    Report

    Report Number
    2647876-2023-00453
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    September 7, 2023
    Report Date
    November 23, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. 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.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE TWO MOLECULAR FALSE POSITIVE RESULTS FOR C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442021, LOT 3130613 BACTEC LYTIC/10 ANAER/F AND THE BIOFIRE PLATFORM. 2 VIALS; LOT 3130613; TESTED (B)(6) 2023. BACTEC INSTRUMENT SERIAL (B)(6). BIOFIRE CATALOG RFIT-ASY-0147 LOT 2WDK23. PT. 2: GRAM= GRAM NEGATIVE RODS; CULTURE RESULT= SERRATIA MARCESCENS; BIOFIRE ID= SERRATIA MARCESANS AND CANDIDA TROPICALIS".

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE TWO MOLECULAR FALSE POSITIVE RESULTS FOR C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442021 LOT 3130613 BACTEC LYTIC/10 ANAER/F AND THE BIOFIRE PLATFORM. 2 VIALS; LOT 3130613; TESTED (B)(6) 2023 BACTEC INSTRUMENT SERIAL FB0446 AND FB0445. BIOFIRE CATALOG RFIT-ASY-0147 LOT 2WDK23. PT. 2: GRAM= GRAM NEGATIVE RODS; CULTURE RESULT= SERRATIA MARCESCENS; BIOFIRE ID= SERRATIA MARCESANS AND CANDIDA TROPICALIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103749 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130613 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown