BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 6895967 · Received September 26, 2017

    Report

    Report Number
    1950204-2017-00318
    Event Type
    Injury
    Date Received
    September 26, 2017
    Report Date
    November 27, 2017
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES HAD NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF SHIGELLA SONNEI IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341). VITEK® 2 GAVE AN IDENTIFICATION OF ESCHERICHIA COLI FOR TWO PATIENT ISOLATES. API TESTING IDENTIFIED THE ORGANISMS AS SHIGELLA SONNEI. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED USING THE SINGLE ISOLATE SUBMITTED BY THE CUSTOMER FOR THIS COMPLAINT. THE SUBMITTED ISOLATE (M0320) WAS SUBCULTURED, AND TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH VITEK® 2 GN ID CARDS FROM THE CUSTOMER AND RANDOM LOTS, IN DUPLICATE, API 20E, VITEK® MS, AND 16S SEQUENCING. THE RESULTS WERE AS FOLLOWS: VITEK® 2 GN ID: ALL FOUR GN CARDS TESTED GAVE ACCEPTABLE IDENTIFICATIONS OF SHIGELLA GROUP WITH AN ANALYSIS MESSAGE TO CONFIRM BY SEROLOGICAL TESTS. API 20E: GOOD IDENTIFICATION OF SHIGELLA SONNEI ALSO WITH A NOTE TO CONFIRM BY SEROLOGICAL TESTS. VITEK® MS: FINAL IDENTIFICATION OF ESCHERICHIA COLI, WITH A 99 % IDENTITY MATCH. 16S SEQUENCING: FINAL IDENTIFICATION OF ESCHERICHIA COLI, WITH A 99 % IDENTITY MATCH. THE CUSTOMER'S REPORTED VITEK® GN CARD IDENTIFICATION OF E. COLI WAS CORRECT FOR THIS STRAIN. ALTHOUGH THE CUSTOMER'S REPORTED VITEK® GN CARD IDENTIFICATION OF E. COLI IS CORRECT FOR THIS STRAIN, INTERNAL TESTING INDICATES THIS TO BE AN ATYPICAL STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF SHIGELLA SONNEI IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341), LOT 2410127203. VITEK® 2 GAVE AN IDENTIFICATION OF ESCHERICHIA COLI. API TESTING IDENTIFIED THE ORGANISM AS SHIGELLA SONNEI. THE CUSTOMER SENT THE ISOLATE TO (B)(6) FOR SEROTYPING. THE CUSTOMER REPORTED THAT TWO PATIENTS WERE AFFECTED. THE CUSTOMER STATED THAT THERE WAS NO UNNECESSARY MEDICAL PROCEDURES OR TREATMENT GIVEN DUE TO THE DISCREPANT RESULT. THE CUSTOMER REPORTED A DELAY OF UNKNOWN DURATION. FOR PATIENT A, THERE WAS A DELAY IN ANTIBIOTIC TREATMENT. PER THE CUSTOMER REPORT, THERE WAS NO PATIENT HARM OR INJURY DUE TO THE MISIDENTIFICATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674441 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410127203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention