BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 7824232 · Received August 28, 2018

    Report

    Report Number
    1950204-2018-00308
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN THE UNITED STATES WHO REPORTED IDENTIFICATION ISSUES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. MULTIPLE REQUESTS FOR STRAIN SUBMITTAL FROM THE CUSTOMER HAVE BEEN UNSUCCESSFUL. THE CUSTOMER REPORTED SETTING UP THE STRAINS FROM BBL BLOOD AGAR. THEY CHECK STERILITY OF THEIR SALINE EVERY DAY AND AUTOCLAVE THEIR DISPENSETTE. PURITY PLATES ARE SET UP FOR EACH ISOLATE. NO OTHER SET UP INFORMATION WAS PROVIDED. IT WAS NOTED THAT FSE "REPLACED READER SECTION A LEDGE, BELT AND SPRINGS. CLEANED OPTICS AND INSIDE THE ROLLER PLATE." THE CUSTOMER REPORTED THAT THEY HAD SERVICE COME IN BECAUSE "SIDE A OPTICS WERE GETTING WHITE CARD DUST ON THEM. CARD PLASTIC WAS BEING SHAVED OFF EVERY TIME IT TRIED TO READ A CARD ON SIDE A. WE THINK THIS IS THE PROBLEM. PROBLEMS SEEM TO HAVE SUBSIDED." SEVEN (7) LAB REPORTS WERE SUBMITTED. HOWEVER, WITHOUT A DEFINITIVE ORGANISM IDENTIFICATION, AN ASSESSMENT OF ATYPICAL REACTIONS CANNOT BE PEFORMED. 209815-3 X 2: LOW DISCRIMINATION S. AGALACTIAE / S. ANGINOSUS / S. GORDONII 200932-8: UNIDENTIFIED 201290-1: LOW DISCRIMINATION S. MITIS/ S. ORALIS / G. ADIACENS / K. KRISTINAE 201290-8: UNIDENTIFIED 201303-1: GOOD ID S. PSEUDOPORCINUS 201303-2: GOOD ID S. PSEUDOPORCINUS ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, COMPROMISED VIABILITY OF THE STRAIN, USE OF NON RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS OR AN ATYPICAL STRAIN. HOWEVER, IN THIS CASE IT APPEARS THAT READER LEDGE CONTRIBUTED TO THE IDENTIFICATION ISSUES SINCE PROBLEMS RESOLVED UPON REPLACEMENT. THE VITEK 2 GP ID CARD, LOT # 2420749203, MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED IDENTIFICATION ISSUES IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT (LOT TO 2420749203). THE CUSTOMER REPORTED THAT THE GP CARD DID NOT IDENTIFY MULTIPLE ORGANISMS CORRECTLY, ESPECIALLY VIRIDANS STREPTOCOCCI. THE CUSTOMER STATED REPEAT TESTS WERE EITHER THE SAME IDENTIFICATION OR LOW DISCRIMINATION. FOR ISOLATE 201303-1, BOTH THE INITIAL AND REPEAT TEST RESULTS WERE STREPTOCOCCUS PSEUDOPORCINUS. THE CUSTOMER STATED THAT ISOLATE 201303-1 IS AN ALPHA STREP. THE CUSTOMER DID NOT PROVIDE THE EXPECTED IDENTIFICATION OF THE ISOLATE. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663002 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX, INC. 2420749203 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1