BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 7890169 · Received September 19, 2018

    Report

    Report Number
    1950204-2018-00375
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Report Date
    October 29, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY STRAIN (D-09) AS MORAXELLA GROUP IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT (LOT 2410474203). AN INVESTIGATION WAS PERFORMED. THE CUSTOMER'S CAP D-09 STRAIN AND THE INTERNAL BIOMÉRIEUX CAP D-09 SURVEY STRAIN WERE SUBCULTURED TO TSAB AND MACCONKEY AGAR AND INCUBATED TO 35-37°C FOR 20-22 HOURS. A SECOND SUBCULTURE WAS PERFORMED AND TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH GN CARDS FROM THE CUSTOMER LOT (2410474203) AND A RANDOM LOT (2410593203) IN DUPLICATE AS WELL AS VITEK MS. 911728 (CUSTOMER'S CAP D-09 STRAIN): THE STRAIN GREW ON MAC AGAR AS A NON-LACTOSE FERMENTING ISOLATE. ALL 4 GN CARDS TESTED RESULTED IN LOW DISCRIMINATION ACINETOBACTER LWOFFII/MORAXELLA GROUP. VITEK MS RESULTED IN AN IDENTIFICATION OF ACINETOBACTER LWOFFII WITH A 99.9% CONFIDENCE VALUE. 911691 (BIOMÉRIEUX INTERNAL CAP D-09 STRAIN): THE STRAIN GREW ON MAC AGAR AS A NON-LACTOSE FERMENTING ISOLATE. ALL 4 GN CARDS TESTED RESULTED IN LOW DISCRIMINATION ACINETOBACTER LWOFFII/MORAXELLA GROUP. VITEK MS RESULTED IN AN IDENTIFICATION OF ACINETOBACTER LWOFFII WITH A 99.9% CONFIDENCE VALUE. A REVIEW OF THE CUSTOMERS MORAXELLA GROUP DATA SHOWED NO POSITIVE REACTIONS, DEMONSTRATING ONE ATYPICAL NEGATIVE REACTION (TYRA) FOR AN IDENTIFICATION OF A. LWOFFII ACCORDING TO THE GN KNOWLEDGE BASE. AS A. LWOFFII WAS PART OF THE LOW DISCRIMINATION CALL ON GN CARDS, CARDS ARE PERFORMING AS EXPECTED FOR BOTH STRAINS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY STRAIN (D-09) AS MORAXELLA GROUP IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT (LOT 2410474203). THE CUSTOMER STATED THEY REPORTED THE IDENTIFICATION AS MORAXELLA GROUP AND THE EXPECTED RESULT WAS ACINETOBACTER LWOFFII. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730341 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410474203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1