BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17765405 · Received September 18, 2023

    Report

    Report Number
    3008352382-2023-00143
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. IT WAS DETERMINED BY MANAGEMENT THAT THIS IS NOT A PRODUCT COMPLAINT, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    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.

    Description of Event or Problem · 0

    REPORT 7 OF 7: IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE OF C. TROPICALIS OCCURRED. PROTEUS SPP + CANDIDA TROPICALIS WAS SEEN ON GRAM STAIN HOWEVER CULTURE IN PROGRESS BUT NO YEAST SEEN ON GS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) WE NEVER REPORT OUT ANY ORGANISMS DETECTED ON BIOFIRE THAT ARE NOT ON OUR GRAM STAIN AS WELL, SO WE DID NOT EXPECT TO HAVE A POSITIVE CANDIDA TROPICALIS RESULT. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 7. PROTEUS SPP + CANDIDA TROPICALIS WHAT ORGANISMS GREW ON CULTURE PLATE? 7. CULTURE IN PROGRESS BUT NO YEAST SEEN ON GS.

    Description of Event or Problem · 0

    REPORT 7 OF 7. IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE OF C. TROPICALIS OCCURRED. PROTEUS SPP + CANDIDA TROPICALIS WAS SEEN ON GRAM STAIN HOWEVER CULTURE IN PROGRESS BUT NO YEAST SEEN ON GS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) WE NEVER REPORT OUT ANY ORGANISMS DETECTED ON BIOFIRE THAT ARE NOT ON OUR GRAM STAIN AS WELL, SO WE DID NOT EXPECT TO HAVE A POSITIVE CANDIDA TROPICALIS RESULT. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 7. PROTEUS SPP + CANDIDA TROPICALIS. WHAT ORGANISMS GREW ON CULTURE PLATE? 7. CULTURE IN PROGRESS BUT NO YEAST SEEN ON GS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294078 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3095927 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown