BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 8838773 · Received July 29, 2019

    Report

    Report Number
    1950204-2019-00239
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Report Date
    January 10, 2022
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN ALIGNMENT WITH THE MOST RECENT FDA GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, ISSUED NOVEMBER 8, 2016", BIOMÉRIEUX IS SUBMITTING THIS NOTIFICATION TO FDA TO INFORM THE AGENCY OF THE DECISION TO CEASE REPORTING SPECIFIC VITEK® 2 MALFUNCTION EVENTS AFTER TWO YEARS OF NO OCCURRENCES ASSOCIATED WITH DEATH OR SERIOUS INJURY. FOR THE SPECIFIC COMBINATIONS OF PRODUCT AND MALFUNCTION TYPE, CUSTOMER COMPLAINTS WERE REVIEWED OVER A TWO YEAR PERIOD STARTING FROM THE DATE OF AWARENESS OF THE MOST RECENT EVENT THAT WAS CLASSIFIED AS A SERIOUS INJURY OR DEATH. FOR THE FOLLOWING MALFUNCTION TYPES, THIS REVIEW IDENTIFIED NO ADDITIONAL OCCURRENCES OF BEING ASSOCIATED WITH DEATH OR SERIOUS INJURY FOR TWO YEARS. PRODUCT CODE: LQM. REFERENCE: (B)(4). MALFUNCTION: MISIDENTIFICATION OF BRUCELLA SUIS. FINAL MDR SUBMITTED: 1950204-2019-00239 WE WISH TO INFORM YOU THAT WITH THE COMPLETION OF OUR MDR DATA ANALYSIS, WE HAVE UPDATED OUR MDR CRITERIA FOR VITEK 2 PRODUCT CODE LQM, AND WILL NO LONGER REPORT THESE MALFUNCTION EVENTS BECAUSE THEY HAVE NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY IN THE PAST TWO YEARS. MOVING FORWARD, IF BIOMÉRIEUX BECOMES AWARE OF A DEATH OR SERIOUS INJURY EVENT FOR THE MALFUNCTIONS REFERENCED ABOVE, WE WILL REPORT THAT EVENT TO THE FDA PER THE FDA MDR GUIDANCE, AND WILL UPDATE OUR MDR CRITERIA TO REQUIRE REPORTING THE SPECIFIC ASSOCIATED MALFUNCTION AS REQUIRED BY THIS GUIDANCE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO AN INTERNAL COMPLAINT FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "ANALYSIS ON BRUCELLOSIS EPIDEMIOLOGICAL CHARACTERISTICS IN HAINAN PROVINCE" BY WANG XM, ET AL. THE PUBLICATION NOTED ONE (1) MISIDENTIFICATION OF BRUCELLA MELITENSIS AND FOUR (4) MISIDENTIFICATIONS OF BRUCELLA SUIS AS OCHROBACTRUM ANTHROPI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT, USING SOFTWARE VERSION 7.01. THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF VITEK 2 GN ID TEST KIT USED. ISOLATES, LAB REPORTS, AND TROUBLESHOOTING DETAILS WERE NOT ABLE TO BE OBTAINED FROM THE AUTHORS OF THE PUBLICATION. WITHOUT STRAIN SUBMITTAL THE REPORTED MISIDENTIFICATION CANNOT BE CONFIRMED AND A POTENTIAL CAUSE FOR THE CLAIMED MISIDENTIFICATION CANNOT BE ESTABLISHED. VITEK® 2 SOFTWARE VERSION 9.02 ADDRESSES THE ISSUE OF MISIDENTIFICATION OF BRUCELLA SPECIES AS OCHROBACTRUM ANTHROPI BY ADDING A NOTE THAT STATES, "POSSIBILITY OF BRUCELLA SPECIES." THE LOT NUMBERS OF THE IMPLICATED GN CARDS ARE NOT AVAILABLE, SO COMPLAINT SEARCHES AND QC PERFORMANCE REVIEW OF THE LOTS CANNOT BE PERFORMED. GLOBAL CUSTOMER SERVICE (GCS) QUERIED TRACKWISE (TW) FOR MISIDENTIFICATION OF BRUCELLA SPECIES FROM 12AUG2018 TO 13SEP2019, RETURNING ONLY ONE COMPLAINT AND ASSOCIATED WITH THIS INVESTIGATION. NO CAPAS OR NCMRS WERE OPENED FOR THIS PERFORMANCE ISSUE DURING THE SAME TIME FRAME. GCS REVIEW OF THE MOST RECENT QUARTERLY TREND REPORT, Q1 2019, DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE.

    Description of Event or Problem · 1

    AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "ANALYSIS ON BRUCELLOSIS EPIDEMIOLOGICAL CHARACTERISTICS IN HAINAN PROVINCE" BY WANG XM, ET AL. THE PUBLICATION NOTED ONE (1)MISIDENTIFICATION OF BRUCELLA MELITENSIS AND FOUR (4) MISIDENTIFICATIONS OF BRUCELLA SUIS AS OCHROBACTRUM ANTHROPI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT, USING SOFTWARE VERSION (B)(4). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF VITEK 2 GN ID TEST KIT USED. TRADITIONAL BIOTYPING METHODS IDENTIFIED ELEVEN (11) STRAINS AS BRUCELLA MELITENSIS BIOVAR 3, AND FIVE (5) STRAINS AS BRUCELLA SUIS BIOVAR 3. THERE IS NO INDICATION FROM THE PUBLICATION THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632800 VITEK® 2 GN TEST KIT GN TEST KIT VTK2 20CARDS LQM BIOMÉRIEUX, INC 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown