BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP67 KIT

    MDR report key: 6239071 · Received January 10, 2017

    Report

    Report Number
    1950204-2017-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Report Date
    September 22, 2016
    Product Code
    LON
    PMA / PMN Number
    K122547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE CUSTOMER'S SUBMITTED ISOLATE AND THE SAMPLE RECEIVED FROM API WERE SUBCULTURED. THE CUSTOMER'S ISOLATE DEMONSTRATED ONLY ONE COLONY MORPHOLOGY WHILE THE INTERNAL SURVEY SAMPLE SHOWED TWO DISTINCT COLONIES MORPHOLOGIES, LARGE AND SMALL, ON SUBCULTURE. IDENTIFICATION OF ALL THREE STRAINS WAS CONFIRMED AS STAPHYLOCOCCUS CAPITIS AND TESTING INCLUDED TWO AST- GP67 CARDS FROM THE CUSTOMER'S LOT AND TWO CARDS FROM A RANDOM LOT FOR ALL ISOLATES. ADDITIONAL TESTING INCLUDED AGAR DILUTION (AD), THE REFERENCE METHOD FOR CM01N FORMULATION FOUND ON THIS CARD, BROTH MICRODILUTION (BMD), E-TEST, D-TEST AND KB DISC DIFFUSION. ALL GP-67 CARDS TESTED DUPLICATED THE CUSTOMER'S MIC'S - 0.25, SUSCEPTIBLE. THE REFERENCE AD MIC = 0.125 IS IN AGREEMENT WITH THE VITEK 2 CARDS. THE BMD MIC - 0.25, E-TEST 0.25, AND KB DISC DIFFUSION (26 MM) ARE ALL SUSCEPTIBLE. THE D-TEST WAS NEGATIVE. ALL GP-67 CARDS TESTED DUPLICATED THE CUSTOMER'S MIC'S - 0.25, SUSCEPTIBLE. THE REFERENCE AD MIC = 0.125 IS IN AGREEMENT WITH THE VITEK 2 CARDS. THE BMD MIC - 0.25, E-TEST 0.25, AND KB DISC DIFFUSION (24 MM) ARE ALL SUSCEPTIBLE. THE D-TEST WAS NEGATIVE. ALL GP-67 CARDS GAVE CM MIC'S - 8, RESISTANT. THE REFERENCE AD MIC - 32, IS IN AGREEMENT WITH THE VITEK 2 CARDS. THE BMD MIC >4, E-TEST >256, AND KB DISC DIFFUSION ALL DEMONSTRATE THE INTENDED CM RESISTANCE. THE D-TEST WAS POSITIVE. THE AST-GP67 CARDS ARE PERFORMING AS EXPECTED COMPARED TO THE REFERENCE METHOD. THE INTENDED CM RESISTANCE RESPONSE WAS DETECTED ON THE SMALL COLONY MORPHOLOGY FROM THE INTERNAL SURVEY SAMPLE. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK 2 AST-GP67 KIT (REFERENCE 22226). THE CUSTOMER REPORTED HAVING AN EDUCATIONAL SURVEY WITH API TO DETECT LOW LEVEL RESISTANCE IN CLINDAMYCIN, LINEZOLID, AND CHLORAMPHENICOL. THE CUSTOMER RECOVERED A STAPHYLOCOCCUS CAPITIS AND THE CLINDAMYCIN HAVING A MIC OF - 0.25. THE REPORT RECEIVED BY THE CUSTOMER SAID THAT DETECTING LOW LEVEL RESISTANCE WAS POOR AND THAT THE VITEK 2 WAS THE BEST 76.9%, MICROSCAN AT 68.4%, AND DISK DIFFUSION AT 62.5%. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20139 VITEK® 2 AST-GP67 KIT VITEK® 2 AST-GP67 KIT LON 22226 132392710

    Patients

    Seq Age Sex Outcome Treatment
    1