BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTA3D COMBINATION MODULE LEFT - 200291

    MDR report key: 15867748 · Received November 28, 2022

    Report

    Report Number
    1950204-2022-00047
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 18, 2022
    Report Date
    March 13, 2024
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026047573
    PMA / PMN Number
    K903505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE-POSITIVE INSTRUMENT RESULTS ON THE BACT/ALERT 3D INSTRUMENT- REFERENCE 200291 (SERIAL NUMBER: (B)(6)) WHEN TESTING AN ADVANCED THERAPY MEDICINAL PRODUCT (ATMP). INVESTIGATION RESULTS: COMPLAINT ANALYSIS: SEARCH HAS BEEN PERFORMED FOR COMPLAINT REGISTERED FOR FALSE POSITIVE RESULTS. THE REVIEW DID NOT INDICATE ANY SYSTEMATIC QUALITY ISSUE FOR BACT/ALERT VIRTUO. NO CORRECTIVE OR PREVENTIVE ACTIONS WERE OPENED FOR THIS PERFORMANCE ISSUE DURING THE ANALYZED PERIOD. REVIEW OF THE BACT/ALERT® 3D: THE REVIEW OF THE BACT/ALERT® 3D INDICATES THAT THE USER MIXED UP THE BOTTLE ID AND THE ACCESSION NUMBER. STEPS TO REPRODUCE THE CUSTOMER ISSUE HAS BEEN IDENTIFIED DURING THE INVESTIGATION: THE USER SCANNED THE ACCESSION NUMBER INTO THE BOTTLE ID FIELD. THE INSTRUMENT ADVANCED TO THE ACCESSION NUMBER FIELD BUT CONTINUOUSLY BEEPED TO ALERT THE USER THAT IT DOES NOT RECOGNIZE THE BOTTLE ID / TYPE. THEN, THE USER SCANNED THE BOTTLE ID NUMBER IN THE ACCESSION NUMBER FIELD. THE INSTRUMENT REVERTED BACK TO THE BOTTLE ID FIELD AND CONTINUED TO BEEP TO ALERT THE USER OF AN ISSUE. THE USER PROCEEDED WITH LOADING THE BOTTLE INTO CELL 1A22 WHILE THE INSTRUMENT CONTINUED TO ALERT THE USER WITH BEEPS. AS A CONSEQUENCE, THE INSTRUMENT ASSIGNED THE BOTTLE AS A GENERIC BOTTLE AND THE INSTRUMENT ANALYZED THE BOTTLE WITH THE WRONG ALGORITHM (#9). INDEED, THE APPROPRIATE ALGORITHM HAS A DIFFERENT INITIAL VALUE THRESHOLD. THIS USE ERROR HAS CAUSED THE INSTRUMENT TO FLAG THE BOTTLE AS POSITIVE. WHEN THE CORRECT BOTTLE TYPE IS SELECTED DURING THE LOADING BOTTLE PROCESS, THE INSTRUMENT ANALYZES THE BOTTLE WITH THE APPROPRIATE ALGORITHM (#25) AND THE BOTTLE DOES NOT FLAG POSITIVE. THE BOTTLE HISTORY SHOWS THAT WHEN THE CORRECT BOTTLE ID IS SELECTED, THE INSTRUMENT ASSIGNED THE CORRECT ALGORITHM AND TESTED THE BOTTLE CORRECTLY. THE BOTTLE RESULT WAS NEGATIVE. THE INSTRUMENT IS FUNCTIONING AS DESIGNED BY FLAGGING THE BOTTLE POSITIVE DUE TO THE USE ERROR. INSTRUCTION FOR USE - REVIEW: THE USER MANUAL PROVIDES THE FOLLOWING INSTRUCTIONS TO THE USER TO FOLLOW WHEN LOADING BOTTLES. BACT/ALERT 3D B.50 USER MANUAL 514818-1EN1 REVIEWED; VERIFY THAT THE BOTTLE ID FIELD APPEARS WHITE. THEN SCAN OR MANUALLY ENTER THE BOTTLE ID. IF THE FIELD IS LEFT BLANK WHEN A BOTTLE IS LOADED, THEN THE BOTTLE IS CONSIDERED ANONYMOUSLY LOADED. VERIFY THAT THE CORRECT BOTTLE TYPE IS DISPLAYED ON THE BOTTLE TYPE SCROLL BUTTON. IF THE BOTTLE ID FIELD CONTAINS DATA FROM A GENERIC LABEL, THE BOTTLE TYPE CAN BE MANUALLY ENTERED USING THE BOTTLE TYPE SCROLL BUTTON BEFORE INSERTING THE BOTTLE TO ENSURE PROPER TESTING OF THE BOTTLE. THE INSTRUMENT WILL ALSO BEEP CONTINUOUSLY TO ALERT THE OPERATOR THAT THE BOTTLE TYPE NEEDS TO BE MANUALLY ENTERED. THE AUDIBLE ALERT CAN BE DISABLED BY CALLING BIOMÉRIEUX FOR ASSISTANCE. USER MANUAL ALSO ALERT THE USER WITH A WARNING MESSAGE OF IMPROPER LOADING. CONCLUSION: THE FALSE POSITIVE RESULTS HAS BEEN CAUSED BY AN USE ERROR RELATED TO THE INCORRECT BOTTLE IDENTIFICATION. THE ISSUE HAS BEEN REPRODUCED AND THE INVESTIGATION HAS CONFIRMED THAT THE INSTRUMENT FUNCTIONS AS INTENDED AND THAT THE INSTRUCTION FOR USE MENTION THE STEPS TO CORRECTLY IDENTIFY A BOTTLE.

    Additional Manufacturer Narrative · 0

    THE MDR GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, ISSUED NOVEMBER 8, 2016", SECTION 2.15, ESTABLISHES THAT ONCE A MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, A PRESUMPTION THAT THE MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY HAS BEEN ESTABLISHED. BIOMÉRIEUX HAS PERFORMED A REVIEW AND ANALYSIS OF THE MDR SUBMISSIONS, SPECIFIC TO THE BIOMÉRIEUX BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT. THE REVIEW INCLUDED MDRS SUBMITTED TO THE FDA FROM 01-JAN-2022 TO 22-FEB-2024. BASED UPON OUR REVIEW AND ANALYSIS OF BIOMÉRIEUX BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT MDR SUBMISSIONS, THERE HAVE BEEN NO CUSTOMER CLAIMS OF DEATH OR SERIOUS INJURY IN THE PAST TWO (2) YEARS. EACH HAS BEEN INVESTIGATED OR IS CURRENTLY UNDERGOING INVESTIGATION, AND ANY ISSUES HAVE BEEN ADDRESSED BY THE MANUFACTURING SITE. WITH THE COMPLETION OF OUR MDR DATA ANALYSIS, WE HAVE UPDATED OUR MDR CRITERIA FOR BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT. MALFUNCTION EVENTS FOR MEDICAL DEVICE PROBLEM CODE: A090804, FALSE POSITIVE RESULT WILL NO LONGER BE REPORTED FOR ALL BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT (PRODUCT CODES: MDB, MZC) AS THESE EVENTS ARE NOT "LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY" IF THEY WERE TO RECUR. MOVING FORWARD, IF WE BECOME AWARE OF A DEATH OR SERIOUS INJURY EVENT RELATED TO NONSTANDARD DEVICE RESULTS OBTAINED WITH AN BACT/ALERT® REAGENTS OR VIRTUO® INSTRUMENT, WE WILL REPORT THAT EVENT TO THE FDA PER THE FDA MDR GUIDANCE AND UPDATE OUR MDR CRITERIA TO INCLUDE REPORTING THE SPECIFIC ASSOCIATED MALFUNCTION AS REQUIRED BY THE MDR GUIDANCE.

    Description of Event or Problem · 0

    INTENDED USE: THE BACT/ALERT® 3D MICROBIAL DETECTION SYSTEM IS AN AUTOMATED TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING AEROBIC AND ANAEROBIC MEDIA INOCULATED WITH PATIENT SPECIMENS SUSPECTED OF HAVING BACTEREMIA, FUNGEMIA, AND/OR MYCOBACTEREMIA. CLINICAL USE: THE FOLLOWING SPECIMEN TYPES CAN BE USED IN THE SYSTEM: BLOOD; STERILE BODY FLUIDS. INDUSTRY USE: THE SYSTEM MONITORS FOR BACTERIAL CONTAMINATION IN SAMPLES. THE BACT/ALERT® 3D MICROBIAL DETECTION SYSTEM IS INTENDED FOR LABORATORY USE BY TRAINED, PROFESSIONAL, CLINICAL AND INDUSTRY USERS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE-POSITIVE INSTRUMENT RESULTS ON THE BACT/ALERT 3D INSTRUMENT- REFERENCE 200291 (SERIAL NUMBER : (B)(4)) WHEN TESTING AN ADVANCED THERAPY MEDICINAL PRODUCT (ATMP). FOR THE MOMENT, NO INFORMATION HAS BEEN REPORTED REGARDING A POTENTIAL SUBCULTURE OF THE POSITIVE BOTTLE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENTS. THIS DISCREPANCY WAS REVIEWED FOR VIGILANCE REPORTING ACCORDING TO 21 CFR 803 CONCERNING MEDICAL DEVICE REPORTING. PER BIOMÉRIEUX INTERNAL STANDARD OPERATING PROCEDURES, FALSE POSITIVE INSTRUMENT RESULT IN ASSOCIATION WITH BACT/ALERT 3D COULD HAVE A NEGATIVE INFLUENCE ON THE MEDICAL DIAGNOSIS AND POTENTIALLY ON THE TREATMENT (UNNECESSARY ANTIMICROBIALS). THIS REVIEW HAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA FOR REPORTING AS A MALFUNCTION. ALTHOUGH THIS EVENT DOES NOT ALLEGE THAT DEATH OR SERIOUS INJURY ACTUALLY OCCURRED, IT HAS BEEN DETERMINED THAT THERE IS POTENTIAL FOR SERIOUS INJURY SHOULD THE SITUATION RECUR WHILE TESTING A PATIENT ISOLATE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053613 BTA3D COMBINATION MODULE LEFT - 200291 BTA3D COMBINATION MODULE LEFT - 200291 MDB BIOMERIEUX INC. 200291 03573026047573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown