BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 AST-P634 TEST KIT

    MDR report key: 7732707 · Received July 30, 2018

    Report

    Report Number
    1950204-2018-00277
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Report Date
    October 3, 2018
    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 INVESTIGATION WAS INITIATED DUE TO DISCREPANT CEFOXITIN SCREEN TEST (OXSF) RESULTS FOR NINE (9) STAPHYLOCOCCUS AUREUS PATIENT ISOLATES ASSOCIATED WITH VITEK® 2 V7.01 SOFTWARE, AST-P634 CARD. THE PRESENCE OF (B)(6) STRAIN WAS CONFIRMED BY PCR MECA POSITIVE FOR ALL STRAINS. THE REFERENCE METHOD USED FOR CEFOXITIN SCREEN TEST IN DEVELOPMENT, DISC DIFFUSION FOR CEFOXITIN (FOX), GAVE RESISTANT RESULTS. TESTS PERFORMED ON THE P634 CARD AND VITEK 2 V7.01 SYSTEM: - AES PARAMETERS : GLOBAL EUROPEAN BASED + PHENOTYPIC - TEST OF THE CUSTOMER LOT 7340619203 CALLED CL1. - TEST OF THE SECOND CUSTOMER LOT 7340690403 CALLED CL2. - TEST OF THE THIRD CUSTOMER LOT 7340502403 CALLED CL3, ONLY FOR STRAIN Q6. - TEST OF ONE (1) RANDOM LOT 7340467403 CALLED RL. - THE LOTS WERE TESTED FROM TSAB SUBCULTURE. - VITEK 2 VERSION V7.01 AND THE NEW VERSION 8.01 WERE TESTED IN PARALLEL. ON VITEK 2 SYSTEM VERSION 7.01 : - FALSE SUSCEPTIBLE OXACILLIN RESULTS WERE REPRODUCED INTERNALLY, WHICH LEAD TO A VERY MAJOR CATEGORY ERROR FOR STRAINS Q2, Q6 AND Q8. - NEGATIVE OXSF RESULTS WERE REPRODUCED INTERNALLY FOR ALL STRAINS, WHICH LEAD TO THE NON-DETECTION OF THE MRSA ISOLATE FOR STRAINS Q2, Q4 AND Q7. STUDY OF GROWTH GRAPHS SHOWED SOME STRAINS HAD LATE GROWTH OR NO GROWTH IN THE OXSF WELL, OR ATYPICAL GROWTH IN THE POSITIVE CONTROL WELL IN VITEK 2 V7.01. --> THE NEW SOFTWARE VERSION 8.01 IMPROVES THE DETECTION OF THE (B)(6) PHENOTYPE, EXCEPT FOR STRAIN Q7, SINCE OXSF TEST WAS OBTAINED POSITIVE, AND AES SYSTEM GAVE "MODIFICATION OF PBP" PHENOTYPE (OXSF KNOWLEDGE BASE WAS MODIFIED IN THIS NEW VERSION).

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 AST-P634 TEST KIT (REFERENCE (B)(4)). THE CUSTOMER REPORTED HAVING A NUMBER OF STAPHYLOCOCCI ANTICIPATING RESULTS TO BE (B)(6) BUT GOT BACK (B)(6). UPON FURTHER TESTING THESE ISOLATES WERE (B)(6) SO THEY WERE (B)(6). THERE WERE NINE (9) DIFFERENT ISOLATES FROM NINE (9) PATIENTS: NOTIFICATION , PATIENT NUMBER: MDR #: (B)(4) (B)(6) 1950204-2018-00268; (B)(4) (B)(6) 1950204-2018-00269; (B)(4) (B)(6) 1950204-2018-00270; (B)(4) (B)(6) 1950204-2018-00271; (B)(4) (B)(6) 1950204-2018-00272; (B)(4) (B)(6) 1950204-2018-00273; (B)(4) (B)(6) 1950204-2018-00274; (B)(4) (B)(6) 1950204-2018-00276; (B)(4) (B)(6) 1950204-2018-00277. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574228 VITEK®2 AST-P634 TEST KIT VITEK®2 AST-P634 TEST KIT LON BIOMERIEUX, INC 7340619203

    Patients

    Seq Age Sex Outcome Treatment
    1