BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-YS08 TEST KIT.

    MDR report key: 7125873 · Received December 18, 2017

    Report

    Report Number
    1950204-2017-00461
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Report Date
    May 18, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    NGZ
    PMA / PMN Number
    K061945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX AN OUT OF RANGE LOW (OORL) FLUCONAZOLE (FLU) RESULT FOR A CANDIDA KRUSEI QUALITY CONTROL STRAIN (ATCC 62058), IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. THE CUSTOMER SUBMITTED THE STRAIN AND CARDS FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. ON VTEK 2 (V7.01), TESTS WERE PERFORMED WITH TWO C. KRUSEI ATCC 6258 STRAINS (INTERNAL REFERENCE STRAIN AND CUSTOMER STRAIN), FROM SDA SUBCULTURED UNDER AEROBIC ATMOSPHERE AS RECOMMENDED. TWO (2) AST-YS08 CARDS LOTS WHICH INCLUDED THE CUSTOMER LOT (2880150203) AND RANDOM LOT (2880297203) WERE TESTED IN DUPLICATE. THE FLU RESULTS WERE MIC = 8 MG/L FOR BOTH LOTS AND WITH BOTH STRAINS TESTED. THE CUSTOMER ISSUE WAS NOT DUPLICATED. THE VITEK 2 AST-YS08 CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX AN OUT OF RANGE LOW (OORL) FLUCONAZOLE RESULT FOR A CANDIDA KRUSEI QUALITY CONTROL STRAIN (ATCC 62058), IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. THE CUSTOMER TESTED THE STRAIN TWICE, BY USING THE AST-YS08 CARD ON TWO DIFFERENT INSTRUMENTS. THE RESULT WAS MIC = 4 FOR BOTH TESTS WITH THE EXPECTED RANGE OF MIC 8 >/= 64. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A QUALITY CONTROL SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904207 VITEK® 2 AST-YS08 TEST KIT. VITEK® 2 AST-YS08 TEST KIT. NGZ BIOMERIEUX, INC 2880150203

    Patients

    Seq Age Sex Outcome Treatment
    1