BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P635 TEST KIT

    MDR report key: 8397114 · Received March 6, 2019

    Report

    Report Number
    1950204-2019-00056
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    December 2, 2018
    Report Date
    May 21, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE (B)(6)REGARDING A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR STAPHYLOCOCCUS AUREUS WHEN TESTING WITH THE VITEK® 2 AST-P635 TEST KIT. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE (B)(6) STRAIN WAS CONFIRMED BY PCR MECA/MECC NEGATIVE RESULT AND A SUSCEPTIBLE CEFOXITIN DISC DIFFUSION RESULT (D = 26 MM, SUSCEPTIBLE). THE REFERENCE METHOD FOR OXACILLIN (AGAR DILUTION) GAVE A SUSCEPTIBLE RESULT (MIC = 0.25 MG/L). TESTS WERE PERFORMED ON THE AST-P635 CARD AND SYSTEM VITEK 2 V8.01 [ADVANCED EXPERT SYSTEM (AES) PARAMETERS: GLOBAL EUROPEAN BASED + PHENOTYPIC]. TWO AST-P635 CARDS (CUSTOMER LOT 7350907203 CALLED CL AND A RANDOM LOT 7350690403 CALLED RL) WERE TESTED FROM TSAB (TSS BMX) SUBCULTURE. - NEGATIVE OXSF TESTS ON BOTH LOTS TESTED - OXACILLIN (OX) MICS <= 0.25 MG/L SUSCEPTIBLE ON BOTH LOTS TESTED. - AES "ACQUIRED PENICILLINASE" PHENOTYPE ON BOTH LOTS TESTED. THE NEGATIVE OXSF TESTS ARE CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB S). THE VITEK 2 OX MIC ARE WITHIN ESSENTIAL AGREEMENT WITH THE AGAR DILUTION REFERENCE MIC WITHOUT ANY CATEGORY ERRORS. THE CUSTOMER'S FALSE POSITIVE OXSF RESULTS ARE NOT REPRODUCED INTERNALLY. THE INVESTIGATION CONCLUDED THE VITEK 2 AST-P635 CARD IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN RESULT WHEN TESTING WITH THE VITEK® 2 AST-P635 TEST KIT. THE CUSTOMER WAS TESTING A STAPHYLOCOCCUS AUREUS STRAIN FROM A (B)(6) PATIENT IN THE NEONATAL UNIT. ON (B)(6) 2018, THE CUSTOMER HAD ISOLATED A (B)(6) FROM THE PATIENT. ON (B)(6) 2018, THE CUSTOMER ISOLATED A STAPHYLOCOCCUS AUREUS FROM AN UMBILICAL SWAB. VITEK 2 AST TESTING ON THIS ISOLATE OBTAINED A RESULT OF (B)(6). THE PHYSICIAN ASKED THAT THE ISOLATE BE MECA TESTED. THE REFERENCE LAB OBTAINED MECA AND MECC NEGATIVE RESULTS. THIS PROMPTED THE CUSTOMER TO RECOVER THEIR ISOLATE FROM THE STORED SLOPE AND REPEAT ALL TESTING. RESULTS WERE AS FOLLOWS: MASTALEX=NEGATIVE. (B)(6). CEFOXITIN DISC TEST=SENSITIVE. VITEK 2 AST STILL GAVE CEFOXITIN SCREEN POSITIVE AND (B)(6). THE CUSTOMER ORIGINALLY HAD PERFORMED TESTING FROM NON-VALIDATED MEDIA, BUT REPEAT TESTING FROM VALIDATED MEDIA OBTAINED THE SAME FALSE POSITIVE CEFOXITIN SCREEN RESULT. THE CUSTOMER REPORTED THAT THE INCORRECT RESULT WAS REPORTED TO THE PHYSICIAN AND THAT THE PATIENT WAS TREATED FOR MRSA. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188678 VITEK® 2 AST-P635 TEST KIT VITEK® 2 AST-P635 TEST KIT LON BIOMERIEUX, INC. 7350907203

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention