BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18008600 · Received October 25, 2023

    Report

    Report Number
    3008352382-2023-00286
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 30, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BD CARIBE, LTD
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 3152014. 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. NO TREND IDENTIFIED FOR BATCH. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    H3. 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 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SHOWED FALSE POSITIVE FOR C. TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. CUSTOMER PROBLEM: CUSTOMER REPORTED FALSE POSITIVE C. TROPICALIS RESULTS WITH BIOFIRE BCID2. BIOFIRE LOT 2Z7Y23. GRAM STAIN HAD GRAM NEGATIVE RODS. BIOFIRE HAD E. COLI, CTX-M AND C. TROPICALIS DETECTED. DID AN INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): FALSE POSITIVE FOR C. TROPICALIS. RESULTS NOT REPORTED IN ERROR. CUSTOMER HAS A RULE IN THE LIS TO NOT REPORT. IF YES, WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): NO. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SHOWED FALSE POSITIVE FOR C. TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. CUSTOMER PROBLEM: CUSTOMER REPORTED FALSE POSITIVE C. TROPICALIS RESULTS WITH BIOFIRE BCID2. BIOFIRE LOT 2Z7Y23. GRAM STAIN HAD GRAM NEGATIVE RODS. BIOFIRE HAD E. COLI, CTX-M AND C. TROPICALIS DETECTED. DID AN INJURY OCCUR?: N. DID ERRONEOUS RESULTS OCCUR?: YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): FALSE POSITIVE FOR C. TROPICALIS. RESULTS NOT REPORTED IN ERROR. CUSTOMER HAS A RULE IN THE LIS TO NOT REPORT. IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): N. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)?: N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111043 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BD CARIBE, LTD 3152014 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown