BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17935953 · Received October 13, 2023

    Report

    Report Number
    3008352382-2023-00199
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 5, 2023
    Report Date
    December 8, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3130610 D4. MEDICAL DEVICE EXPIRATION DATE: 15-FEB-2024 H4. DEVICE MANUFACTURE DATE: 10-MAY-2023 D4. MEDICAL DEVICE LOT #: 3145826 D4. MEDICAL DEVICE EXPIRATION DATE: 29-FEB-2024 H4. DEVICE MANUFACTURE DATE: 25-MAY-2023 H3. 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

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 3130610 & 3145826. 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 BATCHES. COMPLAINT IS UNCONFIRMED BASED ON RETENTION/RETURNED SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B5: DESCRIBE EVENT: UPDATED BASED ON INDIVIDUAL PATIENT DATA. B6: RELEVANT TESTS/LAB DATA: CULTURE AND GRAM STAIN. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 10-OCT-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), 10 MOLECULAR FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442021- BACTEC ANAER LYTIC/F AND THE BIOFIRE PLATFORM. 10 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

    Description of Event or Problem · 0

    REPORT 1 OF 10. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF C. TROPICALIS FOR A PATIENT SAMPLE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442021- BACTEC ANAER LYTIC/F AND THE BIOFIRE PLATFORM. CUSTOMER PROVIDED BIOFIRE CATALOG AND LOT NUMBER: 2USQC23 LOT 1254923. ADDITIONAL INFORMATION PROVIDED 9/28: ADJUSTMENT TO INCIDENT START DATE (B)(6) 2023. TESTED ON BACTEC S/N (B)(6). BIOFIRE CATALOG/LOG NUMBER NOT PROVIDED. RETURNS ARE AVAILABLE. ADDITIONAL AWARENESS FOR 3 PLUS AERO/F VIALS REPORTED AND NEW CASE (B)(4) CREATED. PT#1 - TESTED (B)(6), BIOFIRE DUAL POSITIVE (ENTEROCOCCUS FAECIUM AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - ENTEROCOCCUS FAECIUM. PT#2 - TESTED (B)(6), BIOFIRE NOT DUAL POSITIVE (CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - PEPTONIPHILUS SP. PT#3 - TESTED 9/5, BIOFIRE DUAL POSITIVE (STAPH EPI AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS EPIDERMIDIS. PT#4 - TESTED (B)(6), BIOFIRE DUAL POSITIVE (STREPTOCOCCUS SPP AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STREPTOCOCCUS CONSTELLATUS. PT#5 -TESTED (B)(6), BIOFIRE DUAL POSITIVE (STREPTOCOCCUS SPP AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STREPTOCOCCUS MITIS/ORALIS. PT#6 - TESTED (B)(6), BIOFIRE NOT DUAL POSITIVE (CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - ABIOTROPHIA DEFECTIVA. PT#7 - TESTED (B)(6), BIOFIRE DUAL POSITIVE (STAPHYLOCOCCUS SPP AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS CAPITIS. PT#8 - TESTED (B)(6), BIOFIRE DUAL POSITIVE (STAPH EPI AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS EPIDERMIDIS. PT#9 - TESTED (B)(6), BIOFIRE DUAL POSITIVE (STAPH AUREUS AND CANDIDA TROPICALIS) GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS AUREUS PT#10 - TESTED (B)(6), BIOFIRE DUAL POSITIVE (STAPH EPI AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS EPIDERMIDIS PATIENTS 1-9, LOT 3130610. PATIENT 10, LOT 3145826".

    Description of Event or Problem · 0

    REPORT 1 OF 10. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF C. TROPICALIS FOR A PATIENT SAMPLE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING FALSE MOLECULAR POSITIVE (IDENTIFICATION OF CANDIDA TROPICALIS) WITH USE OF PRODUCTS 442021- BACTEC ANAER LYTIC/F AND THE BIOFIRE PLATFORM. CUSTOMER PROVIDED BIOFIRE CATALOG AND LOT NUMBER: 2USQC23, LOT 1254923. ADDITIONAL INFORMATION PROVIDED 9/28: ADJUSTMENT TO INCIDENT START DATE - 9/03/2023, TESTED ON BACTEC S/N (B)(6). BIOFIRE CATALOG/LOG NUMBER NOT PROVIDED. RETURNS ARE AVAILABLE. ADDITIONAL AWARENESS FOR 3 PLUS AERO/F VIALS REPORTED AND NEW CASE 02143495 CREATED. PT#1 - TESTED 9/3, BIOFIRE DUAL POSITIVE (ENTEROCOCCUS FAECIUM AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - ENTEROCOCCUS FAECIUM PT#2 - TESTED 9/4, BIOFIRE NOT DUAL POSITIVE (CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - PEPTONIPHILUS SP. PT#3 - TESTED 9/5, BIOFIRE DUAL POSITIVE (STAPH EPI AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS EPIDERMIDIS. PT#4 - TESTED 9/6, BIOFIRE DUAL POSITIVE (STREPTOCOCCUS SPP AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STREPTOCOCCUS CONSTELLATUS. PT#5 -TESTED 9/7, BIOFIRE DUAL POSITIVE (STREPTOCOCCUS SPP AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STREPTOCOCCUS MITIS/ORALIS. PT#6 - TESTED 9/9, BIOFIRE NOT DUAL POSITIVE (CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - ABIOTROPHIA DEFECTIVA. PT#7 - TESTED 9/10, BIOFIRE DUAL POSITIVE (STAPHYLOCOCCUS SPP AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS CAPITIS. PT#8 - TESTED 9/12, BIOFIRE DUAL POSITIVE (STAPH EPI AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS EPIDERMIDIS. PT#9 - TESTED 9/12, BIOFIRE DUAL POSITIVE (STAPH AUREUS AND CANDIDA TROPICALIS) GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS AUREUS. PT#10 - TESTED 9/18, BIOFIRE DUAL POSITIVE (STAPH EPI AND CANDIDA TROPICALIS), GRAM=GPC, CULTURE RESULT - STAPHYLOCOCCUS EPIDERMIDIS. PATIENTS 1-9, LOT 3130610. PATIENT 10, LOT 3145826."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748888 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. SEE H10 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown