BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 6170379 · Received December 13, 2016

    Report

    Report Number
    1950204-2016-00202
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    February 21, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JTO
    PMA / PMN Number
    C1, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE 4 ORGANISMS WERE SUBBED, AND TESTING INCLUDED THE CUSTOMER LOT AND A RANDOM LOT OF GN CARDS. API 20 E WAS ALSO PERFORMED. ISOLATE 911255 (K. OXYTOCA): BOTH CARDS GAVE AN EXCELLENT ID (98%) OF K. PNEUMONIAE SSP PNEUMONIAE. THE API 20 E ALSO GAVE A GOOD ID (97.3%) OF K. PNEUMONIAE SSP PNEUMONIAE. THEREFORE, THE FINAL IDENTIFICATION OF THIS ORGANISM IS K. PNEUMONIAE SSP PNEUMONIAE. ISOLATES 911256 AND 911258 (K. PNEUMONIAE): FOR BOTH ISOLATES, ALL CARDS TESTED GAVE AN EXCELLENT ID (98%) OF K. OXYTOCA. HOWEVER, THE API 20 E GAVE A GOOD ID (97.3%) OF K. PNEUMONIAE SSP PNEUMONIAE, SO THE FINAL IDENTIFICATION OF THESE ORGANISMS IS K. PNEUMONIAE SSP PNEUMONIAE. ISOLATE 911257 (K. PNEUMONIAE): BOTH GN CARDS GAVE A VERY GOOD ID - SLASHLINE OF E. CLOACAE COMPLEX. API 20 E ALSO GAVE A GOOD ID (97.7%) OF E. CLOACAE. THEREFORE, THE FINAL IDENTIFICATION OF THIS ORGANISM IS E. CLOACAE. A COMPARISON OF REACTION RESULTS FOR THE CARDS GIVING THE MISIDENTIFICATION OF K. OXYTOCA TO THE EXPECTED REACTION RESULTS FOR K. PNEUMONIAE SSP PNEUMONIAE REVEALED 1 ATYPICAL NEGATIVE REACTION (BXYL) AND 1 ATYPICAL POSITIVE REACTION (5KG) THAT LED TO THE MISIDENTIFICATION. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. BIOMÉRIEUX WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED TO BIOMÉRIEUX A DISCREPANT RESULT FOR A BLOOD CULTURE ISOLATE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER TESTED A GRAM NEGATIVE BACILLI WHICH WAS IDENTIFIED AS KLEBSIELLA OXYTOCA WITH THE VITEK® 2 GN TEST. THE CUSTOMER STATED THAT THEIR OFFLINE TEST FOR INDOLE WAS NEGATIVE WITH THE KLEBSIELLA OXYTOCA ISOLATE AND SHOULD BE POSITIVE. THE ISOLATE WAS CULTURED ON MACCONKEY BLOOD AGAR. REPEAT TESTING PRODUCED THE SAME RESULT. THE CUSTOMER SENT THE KLEBSIELLA OXYTOCA TO A REFERENCE LABORATORY FOR ID CONFIRMATION. THE ISOLATE WAS IDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE CUSTOMER REPORTED THERE WAS NO IMPACT TO THE PATIENT'S HEALTH OR TREATMENT. THE ISOLATE AND TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819552 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST CARD JTO BIOMERIEUX INC. 241393940

    Patients

    Seq Age Sex Outcome Treatment
    1