BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P635 TEST KIT

    MDR report key: 8232173 · Received January 9, 2019

    Report

    Report Number
    1950204-2019-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Report Date
    March 11, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE RESISTANT OXACILLIN (OX) RESULT FOR A STAPHYLOCOCCUS AUREUS NEQAS STRAIN (DISTRIBUTION 4314 SPECIMEN 4480) IN ASSOCIATION WITH THE VITEK® 2 AST-P635 TEST KIT. THE (B)(6) STRAIN WAS CONFIRMED BY PCR MECA/MECC AS (B)(6), AND KIRBY BAUER CEFOXITIN (FOX KB) WAS SUSCEPTIBLE (D=26,5MM). THE REFERENCE METHOD (AGAR DILUTION) FOR OXACILLIN GAVE A SUSCEPTIBLE RESULT (MIC = 1 MG/L). TESTING WITH VITEK 2 V7.01 (AES PARAMETERS : GLOBAL EUROPEAN BASED + PHENOTYPIC) : TWO AST-P635 CARDS: ONE FROM THE CUSTOMER LOT (7350837403 CALLED CL) AND ONE FROM A RANDOM LOT (7350907203 CALLED RL) WERE TESTED FROM CBA (COS BIOMÉRIEUX) SUBCULTURE. VITEK 2 GAVE OX MICS >/= 4 MG/L R ON BOTH LOTS TESTED. OXSF NEGATIVE TESTS CORRECTED TO POSITIVE BY AES WITH "MODIFICATION OF PBP" PHENOTYPE ON BOTH LOTS TESTED. THE OXSF NEGATIVE TESTS ARE CORRELATED WITH THE REFERENCE DISC DIFFUSION RESULT (FOX KB S) BUT THEIR CORRECTIONS INTO POSITIVE BY AES LEAD TO AN ERRONEOUS DETECTION OF (B)(6) PHENOTYPE. THE FALSE RESISTANT OXACILLIN ON THE AST-P635 CARD WAS CONFIRMED IN-HOUSE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A (B)(6) RESULT FOR A STAPHYLOCOCCUS AUREUS (B)(6) STRAIN (DISTRIBUTION (B)(4) SPECIMEN (B)(6)) IN ASSOCIATION WITH THE VITEK® 2 AST-P635 TEST KIT. THE CUSTOMER REPORTED THAT WHEN USING EUCAST DISK SENSITIVITY TESTING THE STRAIN WAS (B)(6), SO THEY USED THE AST-P635 IN WHICH THE (B)(6) WAS RESISTANT (MIC > 4 MG/L), AND INFERRED CEFOXITIN SCREEN POSITIVE. THE CUSTOMER STATED THEY REPORTED THE ISOLATE AS (B)(6). BIOMÉRIEUX DETERMINED THE CUSTOMER WAS USING INVALIDATED MEDIA (TSA HORSE BLOOD) AND REQUESTED RETESTING WITH VALIDATED MEDIA (TSA + 5% SHEEP BLOOD). THE CUSTOMER REPORTED THAT THE RESULT WAS THE SAME ((B)(6) AND INFERRED CEFOXITIN SCREEN POSITIVE). THIS WAS NOT THE INTENDED RESULT FROM (B)(6). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24995 VITEK® 2 AST-P635 TEST KIT VITEK® 2 AST-P635 TEST KIT LON BIOMERIEUX, INC. 7350837403

    Patients

    Seq Age Sex Outcome Treatment
    1