BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P632 TEST KIT

    MDR report key: 6663406 · Received June 23, 2017

    Report

    Report Number
    1950204-2017-00195
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Report Date
    August 31, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K072668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE VANCOMYCIN RESULTS FOR A STAPHYLOCOCCUS AUREUS QUALITY CONTROL SAMPLE ASSOCIATED WITH THE VITEK® 2 (V7.01) AST-P632 TEST KIT. THE CUSTOMER SUBMITTED THE STRAIN AND AST-P632 CARDS FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE IDENTIFICATION OF THE STAPHYLOCOCCUS AUREUS STRAIN WAS CONFIRMED WITH THE VITEK® 2 GP CARD. THE INTENDED MIC RESULT FOR THE SURVEY SAMPLE (EEQ (B)(6)/DISTRIBUTION EHK-978/SAMPLE VZOREK 5) IS EQUAL TO 4 MG/L (RESISTANT). THE BMD (BROTH MICRO DILUTION) REFERENCE METHOD, WAS THE METHOD USED FOR VANCOMYCIN DEVELOPMENT (FORMULATION VAN04N) FOR THE VITEK® 2 AST-P632 CARD AND IS EQUAL TO 2 MG/L (SUSCEPTIBLE). TWO (2) AST- P632 CARDS, ONE (1) FROM THE CUSTOMER LOT AND ONE (1) FROM A RANDOM LOT, WERE TESTED USING VITEK® 2 V7.01. THE RESULTS WERE: CUSTOMER LOT - VANCOMYCIN MIC = 2 MG/L S (CUSTOMER RESULT WAS REPRODUCED) RANDOM LOT - VANCOMYCIN MIC = 1 MG/L S. THESE RESULTS ARE IN ESSENTIAL AGREEMENT WITH THE REFERENCE METHOD. THE MICS ARE ON THE VANCOMYCIN BREAKPOINTS SO THE CATEGORY CAN BE S OR R (BORDERLINE STRAIN). IN CONCLUSION, THE VITEK® 2 AST-P632 CARDS PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE RESULTS ASSOCIATED WITH THE VITEK® 2 AST-P632 TEST KIT INVOLVING A QUALITY CONTROL SAMPLE. THE CUSTOMER REPORTED FALSE SUSCEPTIBLE RESULTS FOR VANCOMYCIN INVOLVING STAPHYLOCOCCUS AUREUS. THE RESULTS OBTAINED WERE MIC = 2 AND THE TEST WAS REPEATED WITH THE SAME RESULT. THE CUSTOMER PERFORMED ADDITIONAL TESTING USING A MICROTITRE PLATE AND THE RESULT WAS MIC=4. IN ADDITION, THE ETEST® RESULT WAS MIC=3. THERE WAS NO PATIENT AFFECTED OR HARMED AND NO RESULTS WERE DELAYED. NO ERRONEOUS RESULTS WERE REPORTED TO A PHYSICIAN. A INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443980 VITEK® 2 AST-P632 TEST KIT VITEK® 2 AST-P632 TEST CARD LON BIOMERIEUX, INC 7320223203

    Patients

    Seq Age Sex Outcome Treatment
    1