BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18014394 · Received October 26, 2023

    Report

    Report Number
    2647876-2023-00368
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 27, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D4. MEDICAL DEVICE EXPIRATION DATE: 01/19/2024. H4. DEVICE MANUFACTURE DATE: 04/12/2023. D4. MEDICAL DEVICE LOT#: 3102725. B5: DESCRIBE EVENT. REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE RESULT. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 AEROBIC VIALS; LOT 3102725; TESTED 9/8/2023; BACTEC INSTRUMENT SERIAL (B)(6); BIOFIRE CATALOG RFIT-ASY-0147 LOT 2WDK23. PT. 1: GRAM= GRAM NEGATIVE RODS; CULTURE RESULT = PSEUDOMONAS AERUGINOSA; BIOFIRE ID= PSEUDOMONAS AERUGINOSA AND CANDIDA TROPICALIS. CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442023 LOT(S) TO BE DETERMINED BACTEC PLUS AEROB/F AND THE BIOFIRE PLATFORM.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H4. DEVICE MANUFACTURE DATE: UNKNOWN, D4. MEDICAL DEVICE LOT#: UNKNOWN. G5: PMA/510(K)#: ONE ADDITIONAL CODE APPLIES; K222591, 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 1 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE RESULT. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 AEROBIC VIALS; LOT 3102725; TESTED (B)(6) 2023; BACTEC INSTRUMENT SERIAL (B)(6) ; BIOFIRE CATALOG RFIT-ASY-0147 LOT 2WDK23. PT. 1: GRAM= GRAM NEGATIVE RODS; CULTURE RESULT = PSEUDOMONAS AERUGINOSA; BIOFIRE ID= PSEUDOMONAS AERUGINOSA AND CANDIDA TROPICALIS. CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442023 LOT(S) TO BE DETERMINED BACTEC PLUS AEROB/F AND THE BIOFIRE PLATFORM.

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE RESULT. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 AEROBIC VIALS; LOT 3102725; TESTED 9/8/2023; BACTEC INSTRUMENT SERIAL (B)(6); BIOFIRE CATALOG RFIT-ASY-0147 LOT 2WDK23. PT. 1: GRAM= GRAM NEGATIVE RODS; CULTURE RESULT = PSEUDOMONAS AERUGINOSA; BIOFIRE ID= PSEUDOMONAS AERUGINOSA AND CANDIDA TROPICALIS. CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442023 LOT(S) TO BE DETERMINED BACTEC PLUS AEROB/F AND THE BIOFIRE PLATFORM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE RESULT. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO. DID A SERIOUS INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): VIALS FLAGGED POSITIVE AND WERE TESTED WITH MOLECULAR PLATFORM. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? CANDIDA TROPICALIS AND ADDITIONAL ORGANISM. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) JUST THE NON-YEAST ORGANISM. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO. CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442023 LOT(S) TO BE DETERMINED BACTEC PLUS AEROB/F AND THE BIOFIRE PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111676 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3102725 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown