BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT

    MDR report key: 8731263 · Received June 25, 2019

    Report

    Report Number
    1950204-2019-00212
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT OF A FALSE POSITIVE CEFOXITIN SCREEN (OXSF) RESULT FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-P580 TEST KIT (REFERENCE # 22233, LOT # 3600972103) AND FIVE (5) PATIENTS. THE CUSTOMER'S STRAINS WERE NOT RECEIVED FOR THIS INVESTIGATION. SUBMITTAL OF THE ISOLATE IS REQUIRED IN ORDER TO CONFIRM A VITEK® 2 DISCREPANCY COMPARED TO THE REFERENCE METHOD. FURTHER INVESTIGATION IS NOT POSSIBLE. VITEK 2 AST-P580 LOT # 3600972103 MET FINAL QC RELEASE CRITERIA. THE LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE (B)(6) CEFOXITIN SCREEN (OXSF) RESULT FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-P580 TEST KIT AND FIVE (5) PATIENTS. ALTERNATE METHOD TESTING VIA KIRBY-BAUER AND P2P LATEX OBTAINED RESULTS OF "(B)(6)". THERE WAS NO EVIDENCE OF REPEAT TESTING VIA AST-P580 CARD PROVIDED BY THE CUSTOMER. STRAIN 171561, OXFS (B)(6), OXACILLIN TESTED 0.5 SUSCEPTIBLE, FORCED TO RESISTANT BY VITEK 2 ADVANCED EXPERT SYSTEM¿ (AES). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR TREATING PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: FIVE (5) SEPARATE MEDWATCH REPORTS WERE SUBMITTED FOR THIS COMPLAINT, ONE FOR EACH PATIENT STRAIN. STRAIN 158719: MEDWATCH 1950204-2019-00211, STRAIN 171561: MEDWATCH 1950204-2019-00212, STRAIN 198161: MEDWATCH 1950204-2019-00213, STRAIN 170385: MEDWATCH 1950204-2019-00214, STRAIN 177883: MEDWATCH 1950204-2019-00215.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524817 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT VITEK® 2 AST-P580 CARD LON BIOMERIEUX, INC 3600972103

    Patients

    Seq Age Sex Outcome Treatment
    1