BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8728506 · Received June 24, 2019

    Report

    Report Number
    1950204-2019-00206
    Event Type
    Malfunction
    Date Received
    June 24, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A COMPLAINT IN REFERENCE TO A GERMAN PUBLICATION (PMS 80754365: "COMPARISON OF DIFFERENT PHENOTYPIC APPROACHES TO SCREEN AND DETECT MECC-HARBORING (B)(6)") CLAIMING NINE (9) FALSE NEGATIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P580 TEST KIT. BIOMÉRIEUX ATTEMPTS TO CONTACT THE AUTHOR OF THE ARTICLE, AND IDENTIFY THE VITEK 2 USERS THAT PROVIDED TEST RESULTS, HAVE BEEN UNSUCCESSFUL. THEREFORE, NO LABORATORY DATA, SPECIFIC TEST RESULTS, PRODUCT BATCH NUMBER(S), PATIENT IMPACT IF ANY, NOR CONFIRMATORY TESTING VIA REFERENCE METHOD ARE AVAILABLE. SUBMITTAL OF THE ISOLATE IS REQUIRED IN ORDER TO CONFIRM A VITEK 2 DISCREPANCY COMPARED TO THE REFERENCE METHOD. FURTHER INVESTIGATION IS NOT POSSIBLE. THE LOT NUMBERS FOR THE IMPLICATED CARDS TYPES ARE NOT AVAILABLE, SO COMPLAINT SEARCHES AND QC PERFORMANCE REVIEW OF THE LOTS CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    BIOMÉRIEUX RECORDED A COMPLAINT IN REFERENCE TO A (B)(6) PUBLICATION (PMS 80754365: "COMPARISON OF DIFFERENT PHENOTYPIC APPROACHES TO SCREEN AND DETECT MECC-HARBORING (B)(6)") CLAIMING NINE (9) FALSE NEGATIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P580 TEST KIT. TESTING OF THE ISOLATES WITH CLSI REFERENCE CEFOXITIN DISK PROVIDED RESULTS OF "RESISTANT". BIOMÉRIEUX ATTEMPTS TO CONTACT THE AUTHOR OF THE ARTICLE, AND IDENTIFY THE VITEK 2 USERS THAT PROVIDED TEST RESULTS, HAVE BEEN UNSUCCESSFUL. THEREFORE, NO LABORATORY DATA, SPECIFIC TEST RESULTS, PRODUCT BATCH NUMBER(S), PATIENT IMPACT IF ANY, NOR CONFIRMATORY TESTING VIA REFERENCE METHOD ARE AVAILABLE. THERE IS NO INDICATION OR REPORT FROM ANY SOURCE THAT ANY DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: NINE (9) SEPARATE REPORTS WILL BE SUBMITTED FOR THIS COMPLAINT RECORD: 1950204-2019-00202, 1950204-2019-00203, 1950204-2019-00204, 1950204-2019-00205, 1950204-2019-00207, 1950204-2019-00208, 1950204-2019-00209, AND 1950204-2019-00210.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521884 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT VITEK® 2 AST-P580 CARD LON BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1