BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT

    MDR report key: 8244744 · Received January 14, 2019

    Report

    Report Number
    1950204-2019-00008
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026437183
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT WAS CREATED TO CORRECT THE 510(K) NUMBER FROM K103752 TO K053097.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN TEST (OXSF) FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE CUSTOMER HAS NOT SUBMITTED REPEAT VITEK 2 TESTING OR THIS STRAIN FOR INVESTIGATION AS REQUESTED. SUBMITTAL OF THE ISOLATE IS REQUIRED IN ORDER TO CONFIRM A VITEK 2 DISCREPANCY COMPARED TO THE REFERENCE METHOD. THE VITEK 2 AST-GP75 LOT #2750753203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN TEST (OXSF) FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE OXACILLIN (OX) RESULT WAS MIC = 0.5 (SUSCEPTIBLE). ALTERNATE TEST METHODS WERE PERFORMED BY THE CUSTOMER; CEFOXITIN DISC, PBP2 AND VERIGENE WERE ALL NEGATIVE. 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. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN TEST (OXSF) FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE (B)(6) RESULT WAS (B)(6). ALTERNATE TEST METHODS WERE PERFORMED BY THE CUSTOMER; CEFOXITIN DISC, PBP2 AND VERIGENE WERE ALL NEGATIVE. 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. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37131 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT VITEK® 2 AST-GP75 CARD LON BIOMERIEUX, INC 2750753203 03573026437183

    Patients

    Seq Age Sex Outcome Treatment
    1