BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-P652 TEST KIT

    MDR report key: 9813916 · Received March 10, 2020

    Report

    Report Number
    1950204-2020-00046
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN BELGIUM REGARDING A FALSE POSITIVE CEFOXITIN SCREEN (OXSF) RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P652 TEST KIT (REF. (B)(4), LOT 8021232403). INVESTIGATION INV-0907 WAS CONDUCTED BY THE MANUFACTURING SITE. THE INVESTIGATION CONCLUDED THAT WHEN AST-P652 LOT 8021232403 WAS MANUFACTURED ON 11OCT2019, IT CONTAINED A MANUFACTURING CONTAMINANT (ENTEROCOCCUS FAECIUM) IN THE OXSF WELL 4, WHICH IS RESPONSIBLE FOR THE FALSE POSITIVE OXSF RESULT. THE CONTAMINANT APPEARS TO HAVE A SYMBIOTIC RELATIONSHIP WITH STAPHYLOCOCCUS AUREUS AND GROWS MUCH FASTER WHEN CARDS ARE INOCULATED WITH STAPHYLOCOCCUS AUREUS. ONCE THE ENTEROCOCCUS FAECIUM BEGINS TO GROW IN THE OXSF WELL, THE INSTRUMENT DETECTS GROWTH AND CALLS THE OXSF SCREEN POSITIVE, CAUSING AN ATYPICAL POSITIVE RESULT. INVESTIGATIONAL TESTING DETERMINED THAT NOT EVERY CARD FROM THE TIME FRAME OF THE MANUFACTURING POUR WILL GIVE THE ATYPICAL POSITIVE OXSF RESULT. MANUFACTURING LOT REVIEW REVEALED NO EVIDENCE OF OTHER SIMILARLY IMPACTED LOTS. THE TRENDED QUARTERLY DATA PROVIDES EVIDENCE THAT THE COMPLAINT LOT IS AN OUTLIER IN REGARDS TO THE OVERALL NUMBER OF COMPLAINTS RECEIVED. THERE IS NO EVIDENCE OF AN INCREASE OF FALSE POSITIVE OXSF COMPLAINTS WHEN EXCLUDING THE COMPLAINT LOT (AST-P652 LOT 8021232403). FSCA 4712 WAS ISSUED TO NOTIFY CUSTOMERS ABOUT THE FALSE POSITIVE OXSF RESULTS ASSOCIATED WITH AST-P652 LOT 8021232403. CAPA 1704831 WAS INITIATED TO INVESTIGATE THE ROOT CAUSE OF THE EVENTS.SEE SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF (B)(6) CEFOXITIN SCREEN RESULTS FOR (B)(6) IN ASSOCIATION WITH THE VITEK® 2 AST-P652 TEST KIT (REF 421857, LOT 8021232403). DISK DIFFUSION TESTING WAS PERFORMED AS AN ALTERNATIVE METHOD AND OBTAINED (B)(6) (SUSCEPTIBLE) RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE (B)(6) RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275887 VITEK 2 AST-P652 TEST KIT VITEK® 2 AST-P652 TEST KIT LON BIOMERIEUX, INC. 8021232403

    Patients

    Seq Age Sex Outcome Treatment
    1