BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT FA PLUS

    MDR report key: 9861374 · Received March 20, 2020

    Report

    Report Number
    3002769706-2020-00003
    Event Type
    Injury
    Date Received
    March 20, 2020
    Report Date
    October 23, 2020
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POST BOTTLE INOCULATION CONTAMINATION ASSOCIATED WITH THE BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLES (REF. (B)(4), LOT 4054200) WHILE TESTING A SAMPLE FROM A FEMALE CANCER PATIENT RECEIVING CHEMOTHERAPY. IN RESPONSE TO THE CUSTOMER COMPLIANT, BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. THREE HUNDRED RETAINED BOTTLES FROM LOT 4054200 WERE INSPECTED, NO CLOUDY OR TURBID BOTTLES WERE FOUND. BIOMÉRIEUX REVIEWED THE MANUFACTURING BATCH RECORDS, PACKAGING DEFECT LOG, AND FINAL AQL INSPECTION RESULTS ASSOCIATED WITH LOT 4054200, AND FOUND NO ANOMALIES DURING MANUFACTURING THAT WOULD CAUSE OR CONTRIBUTE TO BOTTLE CONTAMINATION. LOT 4054200 MET ALL QUALITY FINISHED GOODS RELEASE CRITERIA. THE BACT/ALERT BOTTLES UNDERGO A STEAM-BASED AUTOCLAVE PROCESS DURING MANUFACTURING. ALL AUTOCLAVE CYCLES HAVE AN EXPOSURE TEMPERATURE OF 121° C. THE ORGANISM IN THIS COMPLAINT WOULD BE KILLED BY THIS AUTOCLAVE CYCLE. REVIEW OF THE BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE PACKAGE INSERT CONFIRMED THERE ARE SUFFICIENT INSTRUCTIONS TO THE CUSTOMER ABOUT HOW TO VISUALLY INSPECT THE BOTTLE BEFORE USE AND PRECAUTIONS TO WARNING THAT PRECAUTIONS MUST BE TAKEN TO PREVENT CONTAMINATION OF THE PATIENT SAMPLE DURING BOTH VENIPUNCTURE AND INOCULATION INTO THE CULTURE BOTTLE. THE ROOT CAUSE OF THE CONTAMINATION RESULT OBTAINED BY THE CUSTOMER COULD NOT BE DETERMINED. THE MOST LIKELY ROOT CAUSE IS THAT THE CONTAMINANT ENTERED THE BOTTLE AT THE TIME THE BOTTLE WAS INOCULATED WITH THE SAMPLE (FROM THE ENVIRONMENT OR OTHER MATERIALS USED IN THE BLOOD CULTURE COLLECTION). THE INSTRUMENT TIMES TO DETECTION (TTD) SUPPORT THIS ROOT CAUSE. REFER TO SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF POST BOTTLE INOCULATION CONTAMINATION FOR A PATIENT IN ASSOCIATION WITH THE BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLES (REF. 410851, LOT 4054200). PATIENT: FEMALE CANCER PATIENT RECEIVING CHEMOTHERAPY. A RESULT OF AN OXIDASE POSITIVE GRAM-NEGATIVE BACILLUS WAS PROVIDED TO THE TREATING PHYSICIAN. THE PATIENT WAS GIVEN PREVENTATIVE TREATMENT AND AN ANTIBIOGRAM WAS DONE. PCR WAS PERFORMED ON THE IMPACTED PATIENT BOTTLES; ALL BOTTLES OBTAINED AN IDENTIFICATION OF ADVENELLA KASMIRENSIS. BIOMÉRIEUX CUSTOMER SERVICE CONFIRMED ADVENELLA KASMIRENSIS IS AN ENVIRONMENTAL ORGANISM. THERE IS ADVERSE PATIENT IMPACT; THE PATIENT RECEIVED PREVENTATIVE TREATMENT BASED UPON AN ERRONEOUS TEST RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323156 BACT/ALERT FA PLUS BACT/ALERT® FA PLUS MDB BIOMERIEUX INC. 4054200 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1