BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17195897 · Received June 24, 2023

    Report

    Report Number
    2647876-2023-00054
    Event Type
    Malfunction
    Date Received
    June 24, 2023
    Date of Event
    May 15, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BD CARIBE, LTD
    Product Code
    MDB
    UDI-DI
    00382904420246
    PMA / PMN Number
    K161306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442024 BATCH NO.: 3012356 CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. 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 ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    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 THAT WITH USE OF BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO PATIENT IMPACT. NO ERRONEOUS RESULTS WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 1 MOLECULAR FP 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ONLY VIABLE ORGANISMS 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) NON-VIABLE C.TROPICALIS DETECTED 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO TESTED ON FT5585 BCID2, LOT # 0182723 BIOFIRE WAS A DUAL POSITIVE - PROTEUS MIRABILIS AND C. TROPICALIS CONFIRMATORY TESTING WAS CULTURE AND ID BY(B)(6) . CULTURE GREW ONLY P. MIRABILIS GRAM STAIN WAS GRAM NEGATIVE RODS ONLY ANAEROBIC BOTTLE WAS RUN ON BCID, SO ONLY 1 MOLECULAR FP FOR THIS CASE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH USE OF BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO PATIENT IMPACT. NO ERRONEOUS RESULTS WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 1 MOLECULAR FP. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ONLY VIABLE ORGANISMS 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) NON-VIABLE C.TROPICALIS DETECTED. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO. TESTED ON FT5585, BCID2, LOT # 0182723, BIOFIRE WAS A DUAL POSITIVE - PROTEUS MIRABILIS AND C. TROPICALIS, CONFIRMATORY TESTING WAS CULTURE AND ID BY MALDI. CULTURE GREW ONLY P. MIRABILIS, GRAM STAIN WAS GRAM NEGATIVE RODS, ONLY ANAEROBIC BOTTLE WAS RUN ON BCID, SO ONLY 1 MOLECULAR FP FOR THIS CASE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000911 BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BD CARIBE, LTD 442024 3012356 00382904420246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown