BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 5188445 · Received October 29, 2015

    Report

    Report Number
    1950204-2015-00084
    Event Type
    Injury
    Date Received
    October 29, 2015
    Report Date
    October 23, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    CL. I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED FOR TWO ISOLATES (S1 AND S2) SUBMITTED BY THE CUSTOMER. INVESTIGATIONAL TESTING INCLUDED THE FOLLOWING. 16S SEQUENCING: S1 = ENTEROBACTER AEROGENES, S2 = CITROBACTER FARMERI VITEK 2 GN ID (CUSTOMER LOT AND RANDOM LOT): S1 = ENTEROBACTER AEROGENES, S2 = CITROBACTER FARMERI VITEK MS: S1 = ENTEROBACTER AEROGENES, S2 = CITROBACTER FARMERI ID32E STRIP: S1 = ENTEROBACTER AEROGENES, S2 = LOW DISCRIMINATION BETWEEN CITROBACTER BRAKII AND CITROBACTER AMALONATICUS/FARMERI THE INVESTIGATION DID NOT DUPLICATE THE RESULTS OBTAINED BY THE CUSTOMER. THE VITEK 2 GN ID RESULTS ARE IN AGREEMENT WITH THE REFERENCE METHOD (16S SEQUENCING). THE VITEK 2 GN ID CARDS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. AN ENTEROBACTER SPECIES ORGANISM MISIDENTIFIED AS RAOULTELLA ORNITHINOLYTICA. THE CUSTOMER DID NOT PROVIDE THE VITEK 2 GN ID RESULTS TO THE TREATING PHYSICIAN. IN ADDITION, THE CUSTOMER SENT THE PATIENT ISOLATES TO A REFERENCE LAB (CNR) FOR CONFIRMATORY TESTING. THE REFERENCE LAB RETURNED RESULTS OF ENTEROBACTER SPECIES. THE CUSTOMER REPORTED THE CNR RESULTS TO THE PHYSICIAN; THERE WAS A DELAY EXCEEDING 24 HOURS IN REPORTING RESULTS DUE TO THE ADDITIONAL TESTING. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718705 VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD JTO BIOMERIEUX, INC 241344840

    Patients

    Seq Age Sex Outcome Treatment
    1 Other