BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N288 TEST KIT

    MDR report key: 6481628 · Received April 11, 2017

    Report

    Report Number
    1950204-2017-00116
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Report Date
    June 28, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTT
    PMA / PMN Number
    K860031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IN THAILAND NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-N288 TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. WITHOUT SUBMITTAL OF THE ISOLATE, A VITEK® 2 IMIPENEM DISCREPANCY COMPARED TO THE REFERENCE METHOD CANNOT BE CONFIRMED. WITHOUT SUBMITTAL OF RAW DATA, GROWTH OF THE ISOLATE CANNOT BE ASSESSED. VITEK® 2 AST-N288 LOT# 7080178403 MET FINAL QUALITY CONTROL (QC) RELEASE CRITERIA. THERE WERE NO ISSUES ON THE INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-N288 TEST KIT. THE CUSTOMER REPORTED THAT THE RESULTS PER VITEK 2 AST-N288 FOR PROTEUS MIRABILIS WERE RESISTANT (R); HOWEVER, DISK DIFFUSION RESULTS WERE SUSCEPTIBLE (S). THE CUSTOMER REPORTED THERE WAS NO INCORRECT TREATMENT; HOWEVER, RESULTS WERE DELAYED FOR TWO TO THREE DAYS DUE TO THE DISCREPANCY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262556 VITEK® 2 AST-N288 TEST KIT VITEK® 2 AST-N288 TEST KIT JTT BIOMERIEUX, INC 7080178403

    Patients

    Seq Age Sex Outcome Treatment
    1