BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-NEGAITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GN73 TEST KIT

    MDR report key: 5973507 · Received September 23, 2016

    Report

    Report Number
    1950204-2016-00135
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Report Date
    February 7, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510: S130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED; HOWEVER, THE CUSTOMER DID NOT COMPLY WITH THE BIOMÉRIEUX REQUEST FOR RAW DATA AND PATIENT ISOLATE SUBMITTAL. THE INVESTIGATION REGARDING A FALSE SUSCEPTIBLE CEFEPIME RESULT FOR ESCHERICHIA COLI, COULD NOT BE COMPLETED, AS ASSESSMENT OF ORGANISM GROWTH IN THE VITEK 2 AST-GN73 CARD CANNOT BE MADE WITHOUT THE RAW DATA OR THE ISOLATE SUBMITTAL. ISOLATE SUBMITTAL IS REQUIRED TO DETERMINE WHETHER THE CEFEPIME RESULT IS DISCREPANT COMPARED TO THE REFERENCE METHOD. A REVIEW OF QUALITY RECORDS CONFIRMED THAT AST-GN73 LOT 5930012403 MET FINAL RELEASE CRITERIA AND NO ISSUES WERE OBSERVED ON INITIAL QC PERFORMANCE TESTING. NO FURTHER INVESTIGATION IS POSSIBLE WITHOUT THE DATA OR ISOLATE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE SUSCEPTIBLE CEFEPIME RESULT FOR ESCHERICHIA COLI IN ASSOCIATION WITH THE VITEK® 2 AST-GN73 TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625587 VITEK® 2 GRAM-NEGAITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GN73 TEST KIT VITEK® 2 AST-GN73 CARD LON BIOMERIEUX, INC 5930012403

    Patients

    Seq Age Sex Outcome Treatment
    1