BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P632 TEST CARD,

    MDR report key: 7034103 · Received November 15, 2017

    Report

    Report Number
    1950204-2017-00385
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Report Date
    March 23, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LON
    PMA / PMN Number
    K111599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED DISCREPANT RESULTS FOR TWO EXTERNAL QUALITY CONTROL (NEQAS) S. AUREUS STRAINS ASSOCIATED WITH VITEK®2 AST-P632 TEST KIT (REFERENCE 415059). AN INVESTIGATION WAS PERFORMED. THE CUSTOMER OBTAINED FALSE SUSCEPTIBLE LINEZOLID (LNZ) RESULTS COMPARED TO THE EXPECTED RESULT BY NEQAS SURVEY (16 MG/L R). THE RESULTS OBTAINED ACCORDING TO THE EEQ REPORT ARE : 708 S (83.5%) / 2 I (0.2%) / 138 R (16.3%). SO, ONLY 16.3% OF PARTICIPANTS IDENTIFIED LINEZOLID RESISTANCE AS INTENDED BY NEQAS SURVEY. VITEK 2 INTERPRETATION ACCORDING TO EUCAST 2017 BREAKPOINTS LNZ : [ S </=4 - R > 4 ]. THE AGAR DILUTION (AD) IS THE REFERENCE METHOD USED TO THE DEVELOPMENT OF THIS FORMULA (LNZ02N) IN AST-P632 CARD : LNZ MIC = 2 MG/L S. THE REPRODUCIBILITY TESTING ON VITEK 2 AST-P632 CARDS FROM TSAB SUBCULTURE, INCLUDED TWO CUSTOMER LOTS (CUSTOMER LOT N°1, CL1 7320346203, CUSTOMER LOT N°2, CL2 7320354403) AND A RANDOM LOT, (RL 7320312403). ALL LOTS GAVE A RESULT OF LNZ MIC = 2 MG/L (S). THE CUSTOMER'S RESULTS WERE DUPLICATED IN-HOUSE AND ARE IN AGREEMENT WITH THE REFERENCE METHOD (AD). THE VITEK 2 RESULTS ARE WITHIN ESSENTIAL AGREEMENT WITH THE REFERENCE AD MIC (2 MG/L) WITHOUT ANY CATEGORY ERROR. THEY ALSO CORRELATED WITH MOST OF THE EEQ REPORT RESULTS (83.5% OF S RESULTS OBTAINED). THE VITEK 2 AST-P632 CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED. NOTE: LIMITATION FOR THIS CARD STATES: THE ABILITY OF THE AST CARD TO DETECT RESISTANCE WITH THE FOLLOWING COMBINATION(S) IS UNKNOWN BECAUSE RESISTANT STRAINS WERE NOT AVAILABLE AT THE TIME OF COMPARATIVE TESTING: LINEZOLID: ENTEROCOCCUS SPP., STAPHYLOCOCCUS SPP., STREPTOCOCCUS AGALACTIAE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 AST-P632 TEST KIT (REFERENCE 415059). THE CUSTOMER REPORTED OBTAINING INCORRECT RESULTS FOR AN EXTERNAL QUALITY CONTROL (B)(4) TEST. TWO (2) DIFFERENT STRAINS OF S. AUREUS WERE TESTED WITH THE SAME LOT. IN THE FIRST CASE, A WRONG RESULT WAS OBTAINED FOR OXACILLIN RESULTING IN (B)(6) ON VITEK®2 AND THE EXPECTED RESULT WAS SENSITIVE. IN THE SECOND CASE, A DIFFERENT STRAIN OF S. AUREUS VITEK®2 WAS SENSITIVE TO LINEZOLID WHILE THE EXPECTED RESULT WAS RESISTANT. THERE IS NO PATIENT INVOLVEMENT AS THIS IS A QUALITY CONTROL SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813948 VITEK® 2 AST-P632 TEST CARD, VITEK® 2 AST-P632 TEST CARD, LON BIOMERIEUX INC. 7320346203

    Patients

    Seq Age Sex Outcome Treatment
    1