BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN67 TEST KIT

    MDR report key: 7902782 · Received September 24, 2018

    Report

    Report Number
    1950204-2018-00389
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Report Date
    November 19, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026398453
    PMA / PMN Number
    K113200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSE RESISTANT PIPERACILLIN/TAZOBACTAM (TZP) RESULTS FOR AN ALCALIGENES FAECALIS CAP SURVEY STRAIN (D-08) WHEN TESTING WITH THE VITEK® 2 AST-GN67 TEST KIT. INITIAL TESTING WAS RESISTANT (MIC>=128) AND REPEAT WAS SUSCEPTIBLE (MIC <=4) WHICH WAS THE EXPECTED RESULT FOR THIS SURVEY STRAIN. THE US CUSTOMER SUBMITTED THEIR CAP D-08 2018 ALCALIGENES FAECALIS SSP FAECALIS STRAIN FOR PIPERACILLIN/TAZOBACTAM (TZP) EVALUATION. BOTH THE FIRST AND SECOND SWAB ISOLATES WERE SUBMITTED FOR EVALUATION. THE CUSTOMER'S TWO CAP D-08 STRAINS AND THE INTERNAL BIOMERIEUX CAP D-08 SURVEY STRAIN WERE SUBBED ON TSAB AND IDENTIFICATIONS WERE CONFIRMED. TESTING WAS PERFORMED ON THE CUSTOMER LOT AND A RANDOM LOT OF AST-GN67 CARDS. BROTH MICRODILUTION (BMD), THE REFERENCE METHOD FOR TZP (TZP03N), WAS ALSO PERFORMED. 911744 (CUSTOMER'S D-08 STRAIN- SWAB 1): BOTH CARDS TESTED GAVE A RESISTANT MIC>=128. BMD GAVE A SUSCEPTIBLE MIC<=4. 911745 (CUSTOMER'S D-08 STRAIN- SWAB 2): BOTH CARDS TESTED GAVE A RESISTANT MIC>=128. BMD GAVE A SUSCEPTIBLE MIC<=4. 911704 (INTERNAL D-08 STRAIN): CUSTOMER CARD LOT GAVE A SUSCEPTIBLE MIC<=4, WHILE RANDOM LOT GAVE AN INTERMEDIATE MIC=64. BMD GAVE A SUSCEPTIBLE MIC<=4. CARD AND REFERENCE METHOD ARE IN AGREEMENT FOR THE CUSTOMER LOT, BUT THE RANDOM LOT RESULTS ARE A MINOR CATEGORY ERROR WHEN COMPARED TO REFERENCE. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. THE MOST RECENT QUARTERLY TREND REVIEW DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE. THE INVESTIGATION CONCLUDED THIS IS AN ATYPICAL STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT RESULTS FOR CAP SURVEY STRAIN (D-08) WHEN TESTING WITH THE VITEK® 2 AST-GN67 TEST KIT. THE ALCALIGENES FAECALIS STRAIN TESTED FALSE RESISTANT FOR PIPERACILLIN/TAZOBACTAM USING GN67 LOT 5870607403. UPON REPEAT TESTING, THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT, WHICH IS THE EXPECTED RESULT FOR THIS SURVEY STRAIN. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742629 VITEK® 2 AST-GN67 TEST KIT VITEK® 2 AST-GN67 TEST KIT LON BIOMERIEUX, INC. 5870607403 03573026398453

    Patients

    Seq Age Sex Outcome Treatment
    1