BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17936755 · Received October 14, 2023

    Report

    Report Number
    3008352382-2023-00204
    Event Type
    Malfunction
    Date Received
    October 14, 2023
    Date of Event
    June 9, 2023
    Report Date
    November 5, 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
    MA, 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. MEDICAL DEVICE LOT: 3102725. DESCRIBE EVENT OR PROBLEM: MEDWATCH REPORT MW5145660. MEDICAL DEVICE EXPIRATION DATE: 01/19/2024 . DEVICE MANUFACTURE DATE: 04/12/2023. H.6 INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO.: 3102725. 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

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. G5. PMA/510(K)#: K222591. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE WITH C. TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. SAT SEP 23 04:55:01 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? C.TROPICALIS AND STAPH EPI. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) GRAM POSITIVE COCCI. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO. WHAT RESULTS WERE REPORTED TO CLINICIANS :STAPHYLOCOCCUS EPIDERMIDIS. WAS PATIENT TREATMENT AFFECTED IN RESPONSE? NO. (B)(6). OCCURRENCE DATE: (B)(6) 2023 - 442023- UNABLE TO PROVIDE LOT NUMBER. RESULT OBTAIN BY BD PRODUCT: STAPHYLOCOCCUS EPIDERMIDIS AND C.TROP. RESULT EXPECTED: STAP.EPI. GRAM STAIN: GRAM POSITIVE COCCI. WHAT ORGANISMS GREW ON CULTURE PLATE? STAPHYLOCOCCUS EPIDERMIDIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) CATALOG NUMBER? RFIT-ASY-0147. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 0592323. WAS THE BIOFIRE RESULT DUAL POSITIVE (I.E. TWO ORGANISMS DETECTED)? YES, STAPHYLOCOCCUS EPIDERMIDIS AND C.TROP. QUANTITY AFFECTED: 1 BOTTLE. BACTEC 442023 MOLECULAR FALSE POSITIVE WITH C.TROPICALIS". MEDWATCH REPORT MW5145660.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE WITH C. TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "T WAS REPORTED BY THE CUSTOMER THAT THERE¿S MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. (B)(6) 2023 04:55:01 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? C.TROPICALIS AND STAPH EPI. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) GRAM POSITIVE COCCI. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO. WHAT RESULTS WERE REPORTED TO CLINICIANS :STAPHYLOCOCCUS EPIDERMIDIS. WAS PATIENT TREATMENT AFFECTED IN RESPONSE? NO. (B)(6). OCCURRENCE DATE: (B)(6) 2023 - 442023- UNABLE TO PROVIDE LOT NUMBER. RESULT OBTAIN BY BD PRODUCT: STAPHYLOCOCCUS EPIDERMIDIS AND C.TROP. RESULT EXPECTED: STAP.EPI. GRAM STAIN: GRAM POSITIVE COCCI. WHAT ORGANISMS GREW ON CULTURE PLATE?STAPHYLOCOCCUS EPIDERMIDIS . WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) CATALOG NUMBER? RFIT-ASY-0147. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 0592323. WAS THE BIOFIRE RESULT DUAL POSITIVE (I.E. TWO ORGANISMS DETECTED)? YES, STAPHYLOCOCCUS EPIDERMIDIS AND C.TROP. QUANTITY AFFECTED: 1 BOTTLE. BACTEC 442023 MOLECULAR FALSE POSITIVE WITH C.TROPICALIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748273 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