BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-N263

    MDR report key: 6999133 · Received November 3, 2017

    Report

    Report Number
    1950204-2017-00364
    Event Type
    Injury
    Date Received
    November 3, 2017
    Report Date
    January 12, 2018
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) HAD NOTIFIED BIOMÉRIEUX OF DISCREPANT SUSCEPTIBILITY RESULTS FOR ESCHERICHIA COLI IN ASSOCIATION WITH VITEK® 2 AST-N263 TEST KIT (REFERENCE 413755, LOT 6630313103). INITIAL SUSCEPTIBILITY TESTING WITH VITEK 2 FOUND A URINE SAMPLE ISOLATE TO BE MULTI-DRUG RESISTANT ESCHERICHIA COLI. THE CUSTOMER SUBMITTED THE SAMPLE TO A REFERENCE LAB TO PERFORM PCR TESTING, WHICH WAS NEGATIVE FOR CARBAPENEMASE. THE CUSTOMER RETESTED THE ISOLATE WITH VITEK 2, WHICH GAVE A RESULT OF SUSCEPTIBLE TO CARBAPENEMS (E.G. IMIPENEM) AS WELL AS OTHER ANTIBIOTICS. AN INTERNAL BIOMERIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER STRAIN WAS NOT AVAILABLE FOR SUBMITTAL. THE ISOLATE IS REQUIRED IN ORDER TO CONFIRM VITEK 2 DISCREPANCIES COMPARED TO THE REFERENCE METHOD. VITEK 2 RAW DATA ARE REQUIRED TO ASSESS ORGANISM GROWTH IN THE CARD. VITEK 2 AST-N263 TEST KIT, LOT # 6630313103 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT SUSCEPTIBILITY RESULTS FOR ESCHERICHIA COLI IN ASSOCIATION WITH VITEK® 2 AST-N263 TEST KIT (REFERENCE 413755, LOT 6630313103). INITIAL SUSCEPTIBILITY TESTING WITH VITEK® 2 FOUND A URINE SAMPLE ISOLATE TO BE MULTI-DRUG RESISTANT ESCHERICHIA COLI. THE PATIENT WAS SUBSEQUENTLY PUT INTO ISOLATION. THE CUSTOMER SUBMITTED THE SAMPLE TO A REFERENCE LAB TO TEST FOR CARBAPENEMASE. THE REFERENCE LAB PERFORMED PCR TESTING, WHICH WAS NEGATIVE FOR CARBAPENEMASE. THE CUSTOMER RETESTED THE ISOLATE WITH VITEK® 2, WHICH GAVE A RESULT OF SUSCEPTIBLE TO CARBAPENEMS (E.G. IMIPENEM) AS WELL AS OTHER ANTIBIOTICS. THE CUSTOMER STATED THAT PATIENT RESULTS WERE AFFECTED AND WRONG RESULTS WERE REPORTED TO A PHYSICIAN. AS A RESULT OF THIS, THE PATIENT WAS INCORRECTLY PUT ON ISOLATION PRECAUTIONS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780895 VITEK® 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-N263 VITEK® 2 AST-N263 LON BIOMÉRIEUX, INC. 6630313103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention