BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS CULTURE BOTTLE

    MDR report key: 7785472 · Received August 15, 2018

    Report

    Report Number
    3002769706-2018-00148
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Report Date
    March 1, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF BOTTLE CONTAMINATION ASSOCIATED WITH BACT/ALERT® FA PLUS CULTURE BOTTLE (P/N 410851). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE INVESTIGATION INCLUDED DATA GATHERING FROM THE CUSTOMER, REVIEW OF BIOMÉRIEUX DOCUMENTATION SPECIFIC TO BACT/ALERT® FA PLUS CULTURE BOTTLES, AND HISTORICAL TRENDING. THE CUSTOMER SPECIFIED THAT UNUSED BOTTLES DID NOT APPEAR TO BE CONTAMINATED AND WERE STORED IN A CLEAN AREA IN BLUE BINS NOT IN THE SHRINK-WRAP. THE CUSTOMER ALSO STATED THAT NURSING STAFF DREW THE BLOOD CULTURE SPECIMENS AND THAT BLOOD CULTURES WERE COLLECTED BY EITHER SYRINGES, BUTTERFLY BLOOD COLLECTION SET OR SOMETIMES VIA AN INTRAVENOUS LINE (IV). THERE WAS NO DELAY IN LOADING THE BOTTLES ONTO THE BACT/ALERT® INSTRUMENT. THE REVIEW OF PRODUCTION RECORDS SHOWED NO NON - CONFORMANCES THAT WOULD AFFECT STERILITY. EACH LOT IS QC TESTED, AND THE SENSOR IN EACH BOTTLE IS 100 % INSPECTED BY A VALIDATED AUTOMATED VISION SYSTEM DURING PACKAGING. THE INVESTIGATOR PERFORMED 100% VISUAL INSPECTION OF BACT/ALERT® FA PLUS LOT 4050594 RETAINED BOTTLES FOR EVIDENCE OF CONTAMINATION. ZERO (0) RETAINED BOTTLES INSPECTED EXHIBITED EVIDENCE OF CONTAMINATION. A HISTORICAL REVIEW OF LAST YEAR'S DATA FOUND NO OTHER SIMILAR COMPLAINTS FOR CONTAMINATION IN BACT/ALERT® FA CULTURE BOTTLES (P/N 410851). A REVIEW OF THE BACT/ALERT® FA PLUS INSTRUCTION FOR USE CONFIRMED IT CONTAINS SUFFICIENT INFORMATION REGARDING THE PROPER HANDLING OF THE BOTTLES TO PREVENT CONTAMINATION AND PRECAUTIONS. THE CUSTOMER PROVIDED TIMES TO POSITIVE FOR EIGHT (8) BOTTLES WITH EITHER BACILLUS OR MICROCOCCUS, AND THEY WERE CONSISTENT WITH THE ORGANISM OR SPORES ENTERING THE BOTTLE AT THE TIME OF INOCULATION. THE CUSTOMER DID NOT FIND ANY BOTTLES CONTAMINATED BEFORE USE. THE CUSTOMER DID NOT RECOVER ANY CONTAMINANT FROM CULTURES OF THEIR ALCOHOL WIPES. THE MOST LIKELY ROOT CAUSE IS THE ORGANISM WAS INTRODUCED INTO THE BOTTLE DURING USE AT THE TESTING SITE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF BOTTLE CONTAMINATION ASSOCIATED WITH BACT/ALERT® PF PLUS CULTURE BOTTLE (REFERENCE 410853). THE CUSTOMER REPORTED A HIGHER AMOUNT OF MICROCOCCUS AND BACILLUS CONTAMINATION AT THEIR FACILITY ASSOCIATED WITH BACT/ALERT PF PLUS AND BACT/ALERT FA PLUS CULTURE BOTTLES. THE CUSTOMER STATED THAT THE ISSUE CAN POSSIBLY BE CONTAMINATION FROM THE ALCOHOL SWABS USED TO CLEAN THE BOTTLES, BUT IS UNCERTAIN. THE CUSTOMER ALSO REPORTED THAT THEY USE THE BACT/ALERT® LIQUID MEDIA FOR MOLECULAR TESTING ON THE BIOFIRE FILM ARRAY INSTRUMENT. ONE PATIENT HAD A BACILLUS ISOLATED FROM A LINE DRAW ON DIFFERENT DAYS. THE PHYSICIAN TREATED THIS PATIENT WITH ANTIBIOTICS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628219 BACT/ALERT® FA PLUS CULTURE BOTTLE BACT/ALERT® FA PLUS CULTURE BOTTLE MDB BIOMERIEUX INC. 4050594 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention