BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT® FA PLUS BOTTLE

    MDR report key: 7664349 · Received July 5, 2018

    Report

    Report Number
    3002769706-2018-00093
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 24AUG2018 BIOMÉRIEUX RECEIVED THE FOLLOWING QUESTIONS FROM FDA: FDA QUESTION 1: WERE THE THREE DIFFERENT PATIENTS IN THREE DIFFERENT LOCATIONS CULTURED USING THE SAME BOTTLE LOT NUMBER IN WHICH THE DIETZIA WAS DISCOVERED? BIOMÉRIEUX ANSWER 1: CORRECT, THERE WERE THREE (3) DIFFERENT PATIENTS IN THREE (3) DIFFERENT LOCATIONS CULTURED USING THE SAME BOTTLE LOT NUMBER IN WHICH THE DIETZIA WAS DISCOVERED. FDA QUESTION 2: HAVE THE DIETZIA ISOLATES BEEN SPECIATED? BIOMÉRIEUX ANSWER 2: WE HAVE MADE SEVERAL ATTEMPTS TO COLLECT THIS INFORMATION AND WE HAVE NOT RECEIVED FURTHER INFORMATION TO DATE FROM THE CUSTOMER. WE REQUESTED THIS INFORMATION ON 11JUN2018, 18JUN2018, AND 01AUG2018. FDA QUESTION 3: HAS IT BEEN DETERMINED IF THE DIETZIA IN THE BOTTLE IS A PRODUCTION CONTAMINANT OR IS IT BEING INTRODUCED DUE TO POOR LABORATORY TECHNIQUE (E.G. DURING THE BLOOD DRAW)? BIOMÉRIEUX ANSWER 3: WE ARE NOT AWARE OF ANY PRODUCTION CONTAMINANTS. DURING THE COURSE OF THE BIOMÉRIEUX INVESTIGATION, THERE WERE NO ISSUES IDENTIFIED TO SUSPECT CONTAMINATION WAS INTRODUCED IN THE BOTTLES DURING THE PRODUCTION PROCESS OF BACT/ALERT® FA PLUS LOT 4050258 BOTTLES. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: BIOMÉRIEUX WAS NOTIFIED OF SUSPECTED INOCULATED BOTTLE CONTAMINATION ASSOCIATED WITH BACT/ALERT® FA PLUS BOTTLE (REFERENCE 410851) LOT 4050258 AS DIETZIA WAS IDENTIFIED FROM THREE (3) BOTTLES THAT WERE DRAWN FROM THREE (3) DIFFERENT LOCATIONS WITHIN THE HOSPITAL. DURING THE COURSE OF THE BIOMÉRIEUX INVESTIGATION, THERE WERE NO ISSUES IDENTIFIED TO SUSPECT CONTAMINATION WAS INTRODUCED IN THE BOTTLES DURING THE PRODUCTION PROCESS OF BACT/ALERT® FA PLUS LOT 4050258 BOTTLES. A HISTORICAL REVIEW CUSTOMER COMPLAINT DATA FOUND NO OTHER SIMILAR CONTAMINATION COMPLAINTS ASSOCIATED WITH BACT/ALERT FA PLUS® (P/N 4108521) LOT 4050258 BOTTLES AND NO OTHER COMPLAINTS FOR DIETZIA CONTAMINATION ACROSS ALL BOTTLE TYPES OVER THE PAST YEAR . THE CUSTOMER HAS NOT PROVIDED BIOMÉRIEUX FOLLOW UP INFORMATION ON THEIR INVESTIGATION REGARDING THE SAMPLE TECHNIQUES FOR BLOOD COLLECTION AS POTENTIAL SOURCES OF CONTAMINATION. THE BIOMÉRIEUX INVESTIGATION HAS DETERMINED THAT THE BOTTLE CONTAMINATION MOST LIKELY OCCURRED AT THE HOSPITAL.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF BOTTLE CONTAMINATION ASSOCIATED WITH BACT/ALERT® FA PLUS BOTTLE (REFERENCE 410851). THE CUSTOMER REPORTED THAT THEY ISOLATED A DIETZIA FROM THREE (3) BOTTLES THAT WERE DRAWN FROM THREE (3) DIFFERENT LOCATIONS WITHIN THE HOSPITAL, AND SUSPECTED CONTAMINATION. THESE WERE ALL DRAWN IN BACT/ALERT® FA PLUS BOTTLES. PATIENT 3: A BLOOD CULTURE WAS COLLECTED ON (B)(6) 2018. THE BOTTLE FLAGGED POSITIVE, AND WAS GRAM STAINED. THE GRAM STAIN RESULT WAS POSITIVE FOR COCCI AND THE SENSOR WAS BRIGHT ORANGE. THE POSITIVE RESULT WAS REPORTED TO THE DOCTOR, BUT IS LIKELY CONTAMINANT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507048 BACT/ALERT® FA PLUS BOTTLE BACT/ALERT® FA PLUS BOTTLE MDB BIOMERIEUX INC. 4050258 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1