BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17745678 · Received September 14, 2023

    Report

    Report Number
    2647876-2023-00136
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 7, 2023
    Report Date
    October 16, 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
    GA, 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 MOLECULAR FALSE POSITIVE. 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 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. REFER TO CUSTOMER LETTER. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT#: (B)(6) (LISTED AS PT#: (B)(6) IN EMAIL): 59 YR OLD FEMALE W/ VISION CHANGE/ HEADACHE NO HARM TO PATIENT, NO DELAY ANAEROBIC LOT#: 3102706, EXPIRE 1/16/2024. COLLECT DATE: ON (B)(6) 2023. POSITIVE ON (B)(6) 2023. GST= GNRS; FILMARRAY DETECTED= E.COLI AND C. TROPICALIS. REPEAT- NO C.TROPICALIS DETECTED. PATIENT DISCHARGED- FINAL - SEPSIS- RESOLVED, UTI. E.COLI BACTEREMIA REPORTED TO PHYSICIAN- E.COLI SEQUENCE#: 446591481713, TESTED ON FT3838, BCID2, LOT#: 0989923, CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN, CULTURE GREW E. COLI. TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 1 BOTTLE. WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: (B)(6). HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO. DID AN INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE# OF ERRORS AND TYPE): 1 MOLECULAR FALSE POSITIVE. CUSTOMER REPORTS A MOLECULAR FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT # (B)(6) (LISTED AS PT #(B)(6) IN EMAIL): 59 YR OLD FEMALE W/ VISION CHANGE/ HEADACHE NO HARM TO PATIENT, NO DELAY ANAEROBIC LOT # 3102706, EXPIRE 1/16/24 COLLECT DATE: (B)(6). POSITIVE (B)(6). GST= GNRS; FILMARRAY DETECTED= E.COLI AND C. TROPICALIS. REPEAT- NO C.TROPICALIS DETECTED. PATIENT DISCHARGED- FINAL - SEPSIS- RESOLVED, UTI. E.COLI BACTEREMIA. REPORTED TO PHYSICIAN- E.COLI. SEQUENCE # (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN. CULTURE GREW E. COLI. TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 1 BOTTLE. WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)?: PATIENT. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: (B)(6). HAZARD, INJURY OR ERRONEOUS RESULTS? : YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR?: NO/ DID AN INJURY OCCUR?: NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 1 MOLECULAR FALSE POSITIVE. CUSTOMER REPORTS A MOLECULAR FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396437 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3102706 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown