BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18266751 · Received December 5, 2023

    Report

    Report Number
    2647876-2023-00621
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    September 9, 2023
    Report Date
    December 11, 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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 3130611. 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

    H.6. INVESTIGATION SUMMARY; CATALOG: 442021; BATCH NO.: 3130611. 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.

    Description of Event or Problem · 0

    EVENT 4 OF 6, IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), A MOLECULAR FALSE POSITIVE OCCURRED FOR CANDIDA TROPICALIS OCCURRED. EIGHT BOTTLES WERE POSITIVE FOR ENTEROBACTERIA SP AND CANDIDA TROPICALIS, HOWEVER CANDIDA TROPICALIS WAS NEITHER DETECTED ON GRAM STAIN NOR CULTURE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE ARE 8 FALSE MOLECULAR POSITIVES. 7 OF THE VIALS WERE FROM THE REPORTED LOT 3130611 WHILE THE 8TH LOT IS UNKNOWN. SERIAL NUMBERS OF INSTRUMENTS WITH FP BOTTLES: (IF POSSIBLE) (B)(6). BIOFIRE WAS USED? (Y/N), IF YES, CATALOG# AND LOT# CATALOG RFIT=ASY-147, LOT 2UH023. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MOLECULAR FALSE POSITIVE RESULTS FOR C. TROPICALIS.

    Description of Event or Problem · 0

    EVENT 4 OF 6: IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), A MOLECULAR FALSE POSITIVE OCCURRED FOR CANDIDA TROPICALIS OCCURRED. EIGHT BOTTLES WERE POSITIVE FOR ENTEROBACTERIA SP AND CANDIDA TROPICALIS, HOWEVER CANDIDA TROPICALIS WAS NEITHER DETECTED ON GRAM STAIN NOR CULTURE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE ARE 8 FALSE MOLECULAR POSITIVES. 7 OF THE VIALS WERE FROM THE REPORTED LOT 3130611 WHILE THE 8TH LOT IS UNKNOWN. SERIAL NUMBERS OF INSTRUMENTS WITH FP BOTTLES: (IF POSSIBLE) (B)(6), BIOFIRE WAS USED? (Y/N), IF YES, CATALOG# AND LOT# CATALOG RFIT=ASY-147, LOT 2UH023 HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MOLECULAR FALSE POSITIVE RESULTS FOR C. TROPICALIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235334 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130611 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown