BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 AST-P631 TEST KIT

    MDR report key: 7848960 · Received September 5, 2018

    Report

    Report Number
    1950204-2018-00335
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED DUE TO A FALSE POSITIVE CEFOXITIN SCREEN TEST (OXSF) RESULT FOR A STAPHYLOCOCCUS AUREUS FROM A PATIENT ISOLATE ASSOCIATED WITH THE VITEK® 2 AST-P631 TEST KIT AND V8.01 SOFTWARE. THE CUSTOMER SUBMITTED THE STRAIN FOR EVALUATION. THE ABSENCE OF A MRSA STRAIN WAS CONFIRMED BY PCR MECA/MECC NEGATIVE AND A SUSCEPTIBLE CEFOXITIN DISC DIFFUSION RESULT (D=25.5MM). TESTS PERFORMED ON THE AST-P631 CARD AND SYSTEM VITEK 2 V8.01 (AES PARAMETERS : CASFM/EUCAST 2018_V1) : THE CUSTOMER STRAIN WAS TESTED WITH TWO AST-P631 CARDS (ONE FROM CUSTOMER LOT # 7310698203,CL AND ONE FROM A RANDOM LOT # 7310676103, RL) FROM TSAB SUBCULTURE. TEST RESULTS: - NEGATIVE OXSF TESTS AND "ACQUIRED PENICILLINASE" PHENOTYPES WERE GIVEN BY AES SOFTWARE ON BOTH LOTS TESTED. - THE NEGATIVE OXSF TESTS ARE CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB S). CONCLUSION: THE CUSTOMER FALSE POSITIVE OXSF RESULTS ARE NOT REPRODUCED INTERNALLY. THE VITEK 2 AST-P631 CARDS PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A (B)(6) RESULT FOR A (B)(6) STRAIN IN ASSOCIATION WITH THE VITEK®2 AST-P631 TEST KIT (LOT 7310698203). THE CUSTOMER REPORTED THAT THE AST-P631 GAVE A (B)(6) FOR THE (B)(6) STRAIN THAT WAS OBTAINED FROM A PATIENT ISOLATE (JOINT FLUID), USING A TSS SUBCULTURE. THE CEFOXITIN SCREEN (OXSF) TEST WAS (B)(6). REPEAT TESTING WAS NOT PERFORMED ON THE AST-P631 CARD LOT. THE CUSTOMER REPORTED THAT THE CEFOXITIN DISC DIFFUSION METHOD WAS SUSCEPTIBLE AND THE (B)(6) WAS (B)(6). THE IMPACTED STRAIN WAS SENT TO THE (B)(6) AND TESTED BY PCR, IN WHICH RESULTS WERE (B)(6) FOR (B)(6). THE STRAIN WAS THEN CONFIRMED AS A (B)(6). NO PATIENT OUTCOMES WERE REPORTED DUE TO THE REFERENCED ISSUE BUT THERE WAS A DELAY OF ONE WEEK IN REPORTING RESULT. 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
    688152 VITEK®2 AST-P631 TEST KIT VITEK®2 AST-P631 TEST KIT LON BIOMERIEUX, INC. 7310698203

    Patients

    Seq Age Sex Outcome Treatment
    1