BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK®2 AST-N351 TEST KIT

    MDR report key: 7040425 · Received November 17, 2017

    Report

    Report Number
    1950204-2017-00397
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    July 9, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS INITIATED DUE TO FALSE RESISTANT MEROPENEM (MEM) RESULTS ON VITEK®2 V7.01 AST-N351 CARD WITH THREE (3) STRAINS OF ESCHERICHIA COLI AND TWO (2) STRAINS OF K. PNEUMONIAE SSP PNEUMONIAE. THE REFERENCE METHOD (BROTH MICRODILUTION, BMD) WHICH WAS THE METHOD USED FOR MEROPENEM DEVELOPMENT (FORMULATION MEM02N) ON AST-N351 GAVE : S1/S2/S4/S5 : MEM MIC LESS THAN OR EQUAL TO 0.03 MG/L (SUSCEPTIBLE) S3 : MEM MIC = 0.125 MG/L S THE REPRODUCIBILITY TESTING ON VITEK®2 AST-N351 CARDS FROM CBA (COS BMX) SUBCULTURE FOR EACH STRAIN (TWO (2) CARDS OF TWO RANDOM LOTS 7910314103 AND 7910365203) GAVE: MEM MIC LESS THAN OR EQUAL TO 0.25 MG/L S FOR ALL STRAINS AND ON BOTH LOTS TESTED. NOTE : THE INCRIMINATED LOT, 7910163203, EXPIRED. THE CUSTOMER RESISTANT RESULTS ARE NOT REPRODUCED AND ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE BMD MIC WITHOUT CATEGORY ERROR. AST-N351 CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED. NOTE: THE CUSTOMER'S IMPLICATED LOT, AST-N351 LOT 7910163203, IS ASSOCIATED WITH FSCA 3445.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 AST-N351 TEST KIT (REFERENCE 421257). THE CUSTOMER REPORTED INCORRECT SENSITIVITY PATTERNS WITH THE CARD. SIX (6) ISOLATES HAVE BEEN TESTED USING N351 AND VITEK®2 REPORTED THE RESULTS AS IMIPENEM AND MEROPENEM RESISTANT. DURING RETESTING WITH N352 CARDS AND ETEST® THE RESULT WAS FOUND TO BE SENSITIVE. PATIENT RESULTS WERE IMPACTED BY THESE DISCREPANT RESULTS. SEVEN (7) PATIENTS WERE ISOLATED AND TREATED WITH MORE TOXIC ANTIBIOTICS. PATIENT 1 REFERENCE (B)(4), MDR # 1950204-2017-00393, PATIENT 2 REFERENCE (B)(4), MDR # 1950204-2017-00394, PATIENT 3 REFERENCE (B)(4), MDR # 1950204-2017-00395, PATIENT 4 REFERENCE (B)(4), MDR # 1950204-2017-00396, PATIENT 5 REFERENCE (B)(4), MDR # 1950204-2017-00397, PATIENT 6 REFERENCE (B)(4), MDR # 1950204-2017-00398, PATIENT 7 REFERENCE (B)(4), MDR # 1950204-2017-00399. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822159 VITEK®2 AST-N351 TEST KIT VITEK®2 AST-N351 TEST KIT LON BIOMERIEUX INC. 7910163203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention