BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 7875079 · Received September 13, 2018

    Report

    Report Number
    1950204-2018-00361
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Report Date
    October 17, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR CAP SURVEY SPECIMEN D09 WHEN TESTING WITH THE VITEK® 2 GN ID CARD (REF 21341). AN INVESTIGATION WAS PERFORMED. THE CUSTOMER'S CAP D-09 STRAIN AND THE INTERNAL BIOMERIEUX CAP D-09 SURVEY STRAIN WERE SUBBED ON TSAB AND TESTED IN DUPLICATE ON BOTH GN CUSTOMER CARD LOTS AND A RANDOM GN CARD LOT. API 20 NE WAS ALSO PERFORMED. 911702 (CUSTOMER'S D-09 STRAIN): ON 2 OF THE GN CARDS TESTED, A SLASHLINE: MORAXELLA GROUP CALL WAS OBTAINED. ON 1 CARD, AN UNIDENTIFIED ORGANISM CALL WAS OBTAINED. ON 1 CARD, A VERY GOOD IDENTIFICATION OF P. FLUORESCENS WAS OBTAINED, AND ON 2 CARDS, A LOW DISCRIMINATION CALL OF A. LWOFFII/MORAXELLA GROUP WAS OBTAINED. API 20 NE IDENTIFIED THE ORGANISM AS A. LWOFFII, WITH A 91.7% CONFIDENCE VALUE. SINCE A. LWOFFII WAS PART OF THE LOW DISCRIMINATION CALL OBTAINED ON 2 OF THE CARDS, THESE 2 CARDS ARE PERFORMING AS EXPECTED. THE REMAINING 4 CARDS WERE UNABLE TO CORRECTLY IDENTIFY THE STRAIN. 911691 (INTERNAL D-09 STRAIN): ON ALL 6 GN CARDS TESTED, A LOW DISCRIMINATION CALL OF ACINETOBACTER LWOFFII / MORAXELLA GROUP WAS OBTAINED. WHEN API 20 NE WAS PERFORMED, AN IDENTIFICATION OF A. LWOFFII (91.7%) WAS OBTAINED. SINCE A. LWOFFII IS PART OF THE LOW DISCRIMINATION CALL, CARDS ARE PERFORMING AS EXPECTED FOR THE INTERNAL CAP D-09 STRAIN. A COMPARISON OF CUSTOMER CARD REACTION RESULTS FOR A. BAUMANNII AGAINST EXPECTED REACTION RESULTS FOR A. LWOFFII SHOWED 3 ATYPICAL POSITIVE REACTIONS (DGLU, DMNE, O129R) THAT LED TO THE INCORRECT CALL. A COMPARISON OF REACTION RESULTS FOR CARDS GIVING THE MISIDENTIFICATION OF SLASHLINE: MORAXELLA GROUP AGAINST EXPECTED REACTIONS FOR A. LWOFFII SHOWED 1 ATYPICAL NEGATIVE REACTION (TYRA) WHICH LED TO THE INCORRECT CALL. A COMPARISON OF CARD REACTION RESULTS FOR THE UNIDENTIFIED ORGANISM CALL AGAINST EXPECTED REACTION RESULTS FOR A. LWOFFII SHOWED 3 ATYPICAL POSITIVE RESULTS (DGLU, DMAN, CMT) THAT LED TO THE INCORRECT CALL. A COMPARISON OF CARD REACTION RESULTS FOR P. FLUORESCENS AGAINST EXPECTED REACTION RESULTS FOR A. LWOFFII SHOWED 2 ATYPICAL POSITIVE REACTIONS (DGLU, CMT) THAT LED TO THE INCORRECT CALL. AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA, USER SET UP ERROR, OR AN ATYPICAL STRAIN. THE VITEK 2 GN ID CARDS PERFORMED AS INTENDED FOR THE INTERNAL CAP D-09 STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR CAP SURVEY SPECIMEN D09 WHEN TESTING WITH THE VITEK® 2 GN ID CARD (REF 21341). THE EXPECTED ID WAS ACINETOBACTER LWOFFII, AND THE GN CARD IDENTIFIED THE SAMPLE AS ACINETOBACTER BAUMANNII TWICE. INITIAL TESTING WAS PERFORMED WITH THE LOT 2410481403. REPEAT TESTING WAS PERFORMED WITH A DIFFERENT LOT, # 2410595203. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714516 VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410481403 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1