BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17695530 · Received September 6, 2023

    Report

    Report Number
    2647876-2023-00114
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 22, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: B3: DATE OF EVENT: 22-AUG-2023. B5: REPORT 1 OF 6. 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: WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? POSITIVE PCR FOR CANDIDA TROPICALIS. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT): NEGATIVE. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO. CUSTOMER IS REPORTING THAT THEY HAVE MANY ITEM# 442023, LOT# 3102712 (EXPIRATION DATE - 1/17/2024) THAT ARE GIVING FALSE POSITIVE RESULTS FOR PCR TESTING FOR CANDIDA TROPICALIS.

    Additional Manufacturer Narrative · 0

    B.3 DATE OF EVENT: 08/22/2023. H.6. INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO.: 3102712. 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.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

    REPORT 1 OF 6. 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: WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? POSITIVE PCR FOR CANDIDA TROPICALIS. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT): NEGATIVE. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO. CUSTOMER IS REPORTING THAT THEY HAVE MANY ITEM# 442023, LOT# 3102712 (EXPIRATION DATE: 1/17/2024) THAT ARE GIVING FALSE POSITIVE RESULTS FOR PCR TESTING FOR CANDIDA TROPICALIS.

    Description of Event or Problem · 0

    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: WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? POSITIVE PCR FOR CANDIDA TROPICALIS. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT): NEGATIVE. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO. CUSTOMER IS REPORTING THAT THEY HAVE MANY ITEM# 442023, LOT# 3102712 (EXPIRATION DATE - 1/17/2024) THAT ARE GIVING FALSE POSITIVE RESULTS FOR PCR TESTING FOR CANDIDA TROPICALIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: - WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? POSITIVE PCR FOR CANDIDA TROPICALIS. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT): NEGATIVE. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO. CUSTOMER IS REPORTING THAT THEY HAVE MANY ITEM# 442023, LOT# 3102712 (EXPIRATION DATE - 1/17/2024) THAT ARE GIVING FALSE POSITIVE RESULTS FOR PCR TESTING FOR CANDIDA TROPICALIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379244 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3102712 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown