BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT® PF PLUS CULTURE BOTTLE

    MDR report key: 5148438 · Received October 14, 2015

    Report

    Report Number
    3002769706-2015-00116
    Event Type
    Death
    Date Received
    October 14, 2015
    Report Date
    September 29, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K121446
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACT/ALERT PF PLUS INSTRUCTIONS FOR USE (IFU), DOCUMENT NUMBER (B)(4) WAS REVIEWED. IN THE PROCEDURAL NOTES AND PRECAUTIONS SECTION, THE USER IS CAUTIONED TO "OBTAIN BLOOD SAMPLES PRIOR TO INITIATING ANTIBIOTIC THERAPY. IF THIS IS NOT POSSIBLE, DRAW BLOOD IMMEDIATELY BEFORE ADMINISTERING THE NEXT ANTIBIOTIC DOSE." THE NEUTRALIZATION OF ANTIMICROBIALS SECTION PROCEDURE STATES "NEUTRALIZATION OF ANTIMICROBIALS BY ADSORBENT POLYMERIC BEADS VARIES DEPENDING UPON DOSAGE LEVEL AND TIMING OF SPECIMEN COLLECTION... LESS THAN COMPLETE NEUTRALIZATION WAS OBSERVED FOR...CEFTRIAXONE. CEFTRIAXONE WAS NEUTRALIZED AT RANGES OF 50% PSL TO 2% PSL DEPENDING ON THE ORGANISM." NOTE: PSL = PEAK SERUM LEVEL. THE PERFORMANCE CHARACTERISTICS OF THE TEST SECTION SUMMARIZES IN-HOUSE SEEDED STUDIES THAT WERE PERFORMED WITH STREPTOCOCCI, STAPHYLOCOCCUS AUREUS (NCTC 10788) AND STREPTOCOCCUS PNEUMONIAE (ATCC 6305). THE GROUP A STREPTOCOCCI IS FROM THE SAME FAMILY AS STREPTOCOCCUS PYOGENES. A MINIMUM OF 30 REPLICATES FOR EACH SPECIES WERE TESTED, WITH AT LEAST 95% DETECTION ACHIEVED AT THE LIMIT OF DETECTION (LOD). THE BACT/ALERT PF PLUS IFU PROVIDES SUFFICIENT CAUTION TO THE USER ON THE GROWTH AND RECOVERY OF MICROORGANISMS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR BACT/ALERT PF PLUS LOT NUMBER 3042099 WAS CONDUCTED. THERE WERE NO WAIVERS, EXPLANATORY MEMOS, VALIDATIONS, OR RELATED NON-CONFORMANCES ASSOCIATED WITH THE FILLING OR INVERSION PROCESS, AND ALL IN-PROCESS INSPECTIONS MET THE DEFINED ACCEPTANCE CRITERIA. A REVIEW OF THE QUALITY CONTROL PERFORMED FOR THIS LOT WAS PERFORMED. THERE WERE NO OUT OF SPECIFICATION EVENTS OR NON-CONFORMANCES ASSOCIATED WITH THE RELEASE C TESTING. MICROBIOLOGY GROWTH PERFORMANCE TESTING CHALLENGED SEVEN BOTTLES FOR EACH OF THE TWELVE ORGANISMS IN THE TEST PANEL, INCLUDING STREPTOCOCCUS PYOGENES (ATCC 19615). ANTIMICROBIAL NEUTRALIZATION CHALLENGED THREE ORGANISM AND ANTIMICROBIAL COMBINATIONS. ALL GROWTH PERFORMANCE AND ANTIMICROBIAL NEUTRALIZATION TESTS MET THE TIME TO DETECTION (TTD) SPECIFICATIONS. THE MOST PROBABLE CAUSE IS THE RESULT WAS A TRUE NEGATIVE, DUE TO THE SUSCEPTIBILITY OF THE STREPTOCOCCUS PYOGENES TO CEFTRIAXONE. THE TERMINAL SUBCULTURE OF THE BOTTLE FAILED TO YIELD VIABLE ORGANISMS; THUS, THE BOTTLE PERFORMED AS EXPECTED. IN ORDER TO DETERMINE IF A BOTTLE IS POSITIVE, A SUBCULTURE MUST BE PERFORMED UPON COMPLETION OF THE INCUBATION PERIOD TO CONFIRM THE PRESENCE OR ABSENCE OF VIABLE MICROORGANISMS. IN THIS EVENT, THE CUSTOMER PERFORMED A BLIND SUBCULTURE OF THE BOTTLE PRIOR TO LOADING IT INTO THE INSTRUMENT. THIS BLIND SUBCULTURE REVEALED 2 COLONIES OF STREPTOCOCCUS PYOGENES. THE BLOOD CULTURE SAMPLE WAS OBTAINED APPROXIMATELY TWO HOURS AFTER ANTIMICROBIAL THERAPY WAS INITIATED CORRESPONDING WITH THE PEAK SERUM LEVEL OF THE ANTIMICROBIAL AGENT. A TERMINAL SUBCULTURE OF THE BOTTLE WAS PERFORMED, CONFIRMING THE FINAL NEGATIVE BOTTLE RESULT AS DETERMINED BY THE BACT/ALERT SYSTEM. THE BACT/ALERT PF PLUS CULTURE BOTTLE PERFORMED AS EXPECTED AND INTENDED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER NOTIFIED BIOMERIEUX THAT A (B)(6) YEAR OLD MALE PATIENT WITH SEPTIC SHOCK PASSED AWAY WHILE BACT/ALERT PF PLUS CULTURE BOTTLES WERE INCUBATING. OTHER LABORATORY TESTING METHODOLOGY REVEALED A POSITIVE CULTURE RESULT FOR STREPTOCOCCUS PYOGENES. THE BACT/ALERT CULTURE BOTTLES WERE TAKEN AT 0700 HOURS ON (B)(6) 2015. THE BOTTLES WERE LOADED INTO THE INSTRUMENT FOR INCUBATION AT APPROXIMATELY 0930 HOURS ON THE SAME DAY. APPROXIMATELY 2 HOURS PRIOR TO COLLECTING THE BLOOD SAMPLE FOR THE CULTURE BOTTLES, THE PATIENT WAS EMPIRICALLY STARTED ON CEFTRIAXONE. ON (B)(6) 2015, THE PATIENT PASSED AWAY. AFTER THE BOTTLE REACHED A FINAL NEGATIVE DETERMINATION, A SUBCULTURE WAS PERFORMED. NO ORGANISM GREW UPON SUBCULTURE. THIS IS CONSIDERED A FALSE NEGATIVE EVENT, SINCE THE PATIENT IS POSITIVE FOR A MICRO-ORGANISM AND THE CULTURE BOTTLE RESULT IS NEGATIVE FOR THAT ORGANISM. THE PATIENT EXPIRED PRIOR TO ANY RESULTS BEING AVAILABLE FROM THE BACT/ALERT INSTRUMENT. THE RESULTS WERE NOT COMMUNICATED TO THE PHYSICIAN PRIOR TO PATIENT EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680242 BACT/ALERT® PF PLUS CULTURE BOTTLE BACT/ALERT® PF PLUS CULTURE BOTTLE MDB BIOMERIEUX, INC 3042099

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death