BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTA3D CONTROL MODULE, INDUSTRY - 210148

    MDR report key: 12869341 · Received November 24, 2021

    Report

    Report Number
    1950204-2021-00084
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Report Date
    April 6, 2022
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    K903505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMÉRIEUX COMPLETED AN INTERNAL INVESTIGATION IN RESPONSE TO A CUSTOMER COMPLAINT RELATING TO ONE INSTRUMENT FALSE POSITIVE INDUSTRY CULTURE BOTTLE ON ONE BACT/ALERT® 3D DUAL-T SYSTEM WITH CONTROL MODULE SERIAL NUMBER (B)(6) INSTALLED (B)(6) 2018. THE CUSTOMER¿S INSTRUMENT BACK UP DATA WAS REQUESTED BUT NOT PROVIDED FOR INVESTIGATION. THE SHAPE OF THE SUBMITTED BOTTLE GRAPH SUGGESTS THAT THE INSTRUMENT FALSE POSITIVE RESULT WAS SAMPLE RELATED. THE BOTTLE ID SIHJKYGX GRAPH IS ABOUT TWO (2) DAYS LONG; THERE IS A POSITIVE FLAG AT 0.17 DAYS. THERE IS A LARGE DROP IN REFLECTANCE AFTER LOADING, WITH A U-SHAPED RECOVERY TO FLATTEN OUT AT ABOUT 2200 RLU. THERE A SMALL UPWARD SHIFT IN RLU RIGHT BEFORE ONE (1) DAY. THE U-SHAPE LASTS ABOUT THREE (3) TO FOUR (4) HOURS. THIS COULD INDICATE A COLD SAMPLE/BOTTLE OR OTHER SAMPLE EQUILIBRATION IS OCCURRING TO TRIGGER A FALSE POSITIVE. THE ANALYSIS PROVIDED BY THE BIOMÉRIEUX BIOMATH DEPARTMENT INDICATED WHEN A SHARP RISE IN REFLECTANCE OCCURS IT IS FREQUENTLY CAUSED BY SAMPLE INTERACTING WITH THE INDUSTRY BOTTLES. THE BACT/ALERT® IAST BOTTLE INSTRUCTIONS FOR USE (IFU) STATES THE CUSTOMER ¿PRIOR TO ROUTINE USE, THE USER SHOULD VALIDATE THE SUITABILITY OF THE METHOD FOR EACH SAMPLE TYPE AND VOLUME IN THE BACT/ALERT® I AST CULTURE BOTTLES PER THE VALIDATION REQUIREMENTS DESCRIBED IN THE UNITED STATES PHARMACOPEIA (USP) OR EUROPEAN PHARMACOPOEIA (EP)¿. THE INVESTIGATION TEAM ALSO REVIEWED THE BACT/ALERT® I AST IFU AND CONCLUDED THAT THE IFU PROVIDE ADEQUATE DIRECTIONS FOR THE USER. QUERIES OF THE MANUFACTURING DATA, AND THE COMPLAINT DATA DO NOT REVEAL ANY ADVERSE TREND FOR FALSE POSITIVES BY THE RATE ALGORITHM ON THE BACT/ALERT 3D.

    Description of Event or Problem · 0

    AN INDUSTRY CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING AN INSTRUMENT FALSE POSITIVE RESULT IN ASSOCIATION WITH THE BTA3D CONTROL MODULE, INDUSTRY (REF 210148, SERIAL (B)(4)). THE CUSTOMER IS PART OF THE MUSTANG BIO INC. PHARMA - CELLULAR ADVANCED THERAPIES DIVISION. THE INDUSTRY PRODUCT REFERENCE (B)(4) HAS A SIMILAR CLINICAL DEVICE REFERENCE (B)(4) (CONTROL MODULE, BACT/ALERT 3D). THE CUSTOMER REPORTED THAT THEY LOADED THREE (3) CULTURE BOTTLES AND ONE FLAGGED AS POSITIVE WITHIN TWO (2) HOURS. THE CUSTOMER PROVIDED PHOTOS OF THE BOTTLE THAT WAS FLAGGED AS POSITIVE. THE BOTTLE CONTENTS DO NOT APPEAR TO BE TURBID, AND THE SENSOR ON THE BOTTOM OF THE BOTTLE DOES NOT APPEAR TO HAVE CHANGED COLOR (GREY TO YELLOW, INDICATIVE OF A POSITIVE BOTTLE). THE CUSTOMER SUB-CULTURED THE BOTTLE CONTENTS AND REPORTED THAT THERE WAS NO GROWTH AFTER EIGHT (8) DAYS OF INCUBATION. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769006 BTA3D CONTROL MODULE, INDUSTRY - 210148 BTA3D CONTROL MODULE, INDUSTRY MDB BIOMÉRIEUX, INC. 210148

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown