BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® IFN CULTURE BOTTLE

    MDR report key: 8004209 · Received October 25, 2018

    Report

    Report Number
    3002769706-2018-00224
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Report Date
    June 5, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    PMA / PMN Number
    K020815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED DUE TO AN INDUSTRY CUSTOMER'S REPORT OF A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® IFN (REFERENCE 251063). THE INVESTIGATION EXAMINED THE BACT/ALERT IFA LOT 1051275 AND BACT/ALERT IFN LOT 1051030 BOTTLE MANUFACTURING DIRECTIONS, INCLUDING THE FILLING AND PACKAGING RECORDS, AND QUALITY CONTROL DATA FOR GROWTH PROMOTIONS. BOTH LOTS MET ALL RELEASE CRITERIA. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE TWO LOTS FOR DISTRIBUTION TO THE FIELD ON 19DEC2018 AND 13JUL2018 RESPECTIVELY. A HISTORICAL REVIEW OF COMPLAINT DATA DETERMINED NO ADVERSE TREND IS PRESENT. THE INVESTIGATION IS UNABLE TO DETERMINE THE ROOT CAUSE. BASED ON THE INFORMATION AVAILABLE, POSSIBLE ROOT CAUSES ARE: ·THE BOTTLE WAS SUBCULTURED TO CONTAMINATED SOLID MEDIA BECAUSE THE BOTTLE GRAPHS LOOK NEGATIVE WITH NORMAL REFLECTANCE, AND TWO ORGANISMS WERE PRESENT ON THE SUBCULTURE PLATES. THE TWO ORGANISMS COULD BE ENVIRONMENTAL CONTAMINANTS [MICROBACTERIUM SPECIES AND BACILLUS SPECIES]. THE CUSTOMER DID NOT STATE EITHER BOTTLE HAD ANY NOTICEABLE DEFECTS PRIOR TO INOCULATION. PER GRAU, F. H. "NUTRITIONAL REQUIREMENTS OF MICROBACTERIUM THERMOSPHACTUM" APPL. ENVIRONM. MICROBIO. 1979 VOL. 38 PP. 818-820, M. THERMOSPHACTUM REQUIRES LIPIDS FOR GROWTH. THE ORGANISM WAS DETECTED AT THE COMPLAINING SITE WHEN THE BACT/ALERT BOTTLE WAS SUPPLEMENTED WITH FLUID D, WHICH CONTAINS THE LIPID TWEEN 80. IT IS POSSIBLE THERE ARE INSUFFICIENT LIPIDS IN THE IFA OR IFN BOTTLES OR SAMPLE TO ROBUSTLY SUPPORT THE GROWTH OF M. THERMOSPHACTUM. RECOMMENDATIONS TO THE CUSTOMER ARE TO FOLLOW DIRECTIONS IN THE BOTTLE INSTRUCTIONS FOR USE AND TO: PERFORM GRAM STAINS AND SUBCULTURES ON ALL BOTTLES THAT FLAG POSITIVE, OR LOOK SUSPICIOUS TO BE POSITIVE. REPEAT CULTURE TEST ON POSITIVE SAMPLE FOR CONFIRMATION WHEN BOTTLES ARE SUSPECTED TO BE FALSE NEGATIVE. VISUALLY CHECK ALL BOTTLES AND CULTURE MEDIA FOR DAMAGE, OR SIGNS OF CONTAMINATION BEFORE USE. PERFORM DIRECT GRAM STAIN BEFORE INOCULATING BOTTLE IF ORIGINAL SAMPLE APPEARS CLOUDY. CONSIDER ADDITION OF SUPPLEMENTS FOR RECOVERY OF DESIRED ORGANISMS FROM SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® IFN (REFERENCE 251063). THE CUSTOMER REPORTED WHILE TESTING PRODUCT (A CELL GROWTH MEDIUM CALLED "MIXED MEDIA 60", SMOOTH MUSCLE GROWTH) THEY OBTAINED A FALSE NEGATIVE RESULT ON THE BACT/ALERT® 3D INSTRUMENT FOR THE BACT/ALERT IFA AND IFN BOTTLES. THE BOTTLES WERE SUBCULTURED DUE TO A CLOUDY APPEARANCE UPON UNLOADING THEM FROM THE INSTRUMENT. THIS IS AN INDUSTRY CUSTOMER AND THERE IS NO PATIENT ASSOCIATED WITH THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846815 BACT/ALERT® IFN CULTURE BOTTLE BACT/ALERT® IFN CULTURE BOTTLE MDB BIOMERIEUX INC. 1051030

    Patients

    Seq Age Sex Outcome Treatment
    1