BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17730850 · Received September 12, 2023

    Report

    Report Number
    2647876-2023-00125
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    September 1, 2023
    Report Date
    October 19, 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 11-SEP-2023. H.6. INVESTIGATION SUMMARY: CATALOG: 442023, BATCH NO.: 3102725. 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 AND 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 ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION AND RETURNED SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    E.7 INITIAL REPORTER ADDR 1: (B)(6). 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

    PATIENT 1 OF 3. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTION: THE PATIENT # 3 FALSE POSITIVE HAS NOT COME OFF THE INSTRUMENT AGAIN. ONCE IT WAS DEEMED A FALSE POSITIVE, IT WAS PLACED BACK ON THE INSTRUMENT AND HAS NOT BEEN DEEMED POSITIVE SINCE (B)(6): (B)(6) 2023 20:55:36 (GMT). PATIENT #1: (B)(6) 2023. LOT # 3102725. SEQUENCE # (B)(6). CUSTOMER DOESN'T KNOW THE SN OF THE FX THIS WAS TESTED ON BCID2, LOT # 1337923. BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 2: (B)(6) 2023. LOT # 3102725. SEQUENCE # (B)(6). BCID 2, LOT # 1337923. BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS. CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 3: (B)(6) 2023. LOT # 3102725. SEQUENCE #: (B)(6). GRAM STAIN WAS "NO ORGANISMS SEEN." BIOFIRE DETECTED C. TROPICALIS ONLY. BOTTLE WAS PLACED BACK ON THE INSTRUMENT AND DEEMED A FALSE POSITIVE. BOTTLE WAS FLAGGED POSITIVE AGAIN A FEW HOURS LATER, GRAM STAIN WAS NOS, AND THE BIOFIRE RESULTS HAD NO ORGANISMS DETECTED. CUSTOMER PLACED BOTTLE IN INCUBATOR FOR MANUAL INCUBATION AND DID A BLIND SUB AND GRAM STAIN ON DAY 3. FOUND GRAM POSITIVE COCCI IN CLUSTERS ON THE GRAM STAIN. SEE CASE # (B)(4) FOR RECORD OF FALSE POSITIVES. (B)(6) : (B)(6) 2023 20:49:23 (GMT). PATIENT #1: (B)(6) 2023. LOT # 3102725. SEQUENCE # (B)(6). CUSTOMER DOESN'T KNOW THE SN OF THE FX THIS WAS TESTED ON BCID2, LOT # 1337923. BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS. CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 2: (B)(6) 2023. LOT # 3102725. SEQUENCE # (B)(6). BCID 2, LOT # 1337923. BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS. CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 3: (B)(6) 2023. LOT # 3102725. SEQUENCE #: (B)(6). GRAM STAIN WAS "NO ORGANISMS SEEN." BIOFIRE DETECTED C. TROPICALIS ONLY. BOTTLE WAS PLACED BACK ON THE INSTRUMENT AND DEEMED A FALSE POSITIVE. BOTTLE WAS FLAGGED POSITIVE AGAIN A FEW HOURS LATER, GRAM STAIN WAS NOS, AND THE BIOFIRE RESULTS HAD NO ORGANISMS DETECTED. CUSTOMER PLACED BOTTLE IN INCUBATOR FOR MANUAL INCUBATION AND DID A BLIND SUB AND GRAM STAIN ON DAY 3. FOUND GRAM POSITIVE COCCI IN CLUSTERS ON THE GRAM STAIN. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. 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): 3 MOLECULAR FPS IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): NO.

    Description of Event or Problem · 0

    PATIENT 1 OF 3. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTION: THE PATIENT # 3 FALSE POSITIVE HAS NOT COME OFF THE INSTRUMENT AGAIN. ONCE IT WAS DEEMED A FALSE POSITIVE, IT WAS PLACED BACK ON THE INSTRUMENT AND HAS NOT BEEN DEEMED POSITIVE SINCE. (B)(6) PATIENT #1: (B)(6) 2023, LOT # 3102725, SEQUENCE # (B)(4). CUSTOMER DOESN'T KNOW THE SN OF THE FX THIS WAS TESTED ON BCID2, LOT # 1337923. BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS RESULT WAS NOTE REPORTED CONFIRMATORY TESTING WAS CULTURE. PATIENT # 2: (B)(6) 2023, LOT # 3102725, SEQUENCE # (B)(4), BCID 2, LOT # 1337923, BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 3: (B)(6) 2023, LOT # 3102725, SEQUENCE #: (B)(4), GRAM STAIN WAS "NO ORGANISMS SEEN". BIOFIRE DETECTED C. TROPICALIS ONLY BOTTLE WAS PLACED BACK ON THE INSTRUMENT AND DEEMED A FALSE POSITIVE. BOTTLE WAS FLAGGED POSITIVE AGAIN A FEW HOURS LATER, GRAM STAIN WAS NOS, AND THE BIOFIRE RESULTS HAD NO ORGANISMS DETECTED. CUSTOMER PLACED BOTTLE IN INCUBATOR FOR MANUAL INCUBATION AND DID A BLIND SUB AND GRAM STAIN ON DAY 3. FOUND GRAM POSITIVE COCCI IN CLUSTERS ON THE GRAM STAIN. SEE CASE # (B)(4) FOR RECORD OF FALSE POSITIVES (B)(6). PATIENT #1: (B)(6) 2023, LOT # 3102725, SEQUENCE # (B)(4), CUSTOMER DOESN'T KNOW THE SN OF THE FX THIS WAS TESTED ON BCID2, LOT # 1337923. BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 2: (B)(6) 2023, LOT # 3102725, SEQUENCE # (B)(4), BCID 2, LOT # 1337923, BIOFIRE WAS A DUAL POSITIVE - STAPH EPI W/ MECA RESISTANCE, C. TROPICALIS CULTURE GREW STAPH EPI. GRAM STAIN WAS GRAM POSITIVE COCCI IN CLUSTERS. RESULT WAS NOTE REPORTED. CONFIRMATORY TESTING WAS CULTURE. PATIENT # 3: (B)(6) 2023, LOT # 3102725, SEQUENCE #: (B)(4), GRAM STAIN WAS "NO ORGANISMS SEEN". BIOFIRE DETECTED C. TROPICALIS ONLY. BOTTLE WAS PLACED BACK ON THE INSTRUMENT AND DEEMED A FALSE POSITIVE. BOTTLE WAS FLAGGED POSITIVE AGAIN A FEW HOURS LATER, GRAM STAIN WAS NOS, AND THE BIOFIRE RESULTS HAD NO ORGANISMS DETECTED. CUSTOMER PLACED BOTTLE IN INCUBATOR FOR MANUAL INCUBATION AND DID A BLIND SUB AND GRAM STAIN ON DAY 3. FOUND GRAM POSITIVE COCCI IN CLUSTERS ON THE GRAM STAIN. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. 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): 3 MOLECULAR FPS IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173806 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