BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 7216864 · Received January 24, 2018

    Report

    Report Number
    1950204-2018-00047
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Report Date
    April 12, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF ESCHERICHIA COLI AS SALMONELLA ENTERICA SSP DIARIZONAE FOR TWO URINE ISOLATES IN ASSOCIATION WITH THE VITEK® 2 GNTEST KIT. THE CUSTOMER SUBMITTED THE TWO ISOLATES FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE ISOLATES WERE CULTURED AND TESTED ON THE CUSTOMER LOT AND A RANDOM LOT OF GN CARDS IN DUPLICATE. API 20 E WAS ALSO PERFORMED. ISOLATE 911550 (1241163): ALL FOUR (4) CARDS TESTED GAVE AN EXCELLENT ID OF E. COLI. API 20 E ALSO GAVE A VERY GOOD ID (99.9%) OF E. COLI. THEREFORE, THE FINAL IDENTIFICATION IS E. COLI. CUSTOMER CARD REACTION RESULTS WERE NOT PROVIDED AS PART OF THE LAB REPORTS SUBMITTED, SO A COMPARISON OF REACTION RESULTS FOR THE CUSTOMER CARD'S IDENTIFICATION OF S. ENTERICA SSP DIARIZONAE AGAINST EXPECTED RESULTS FOR E. COLI COULD NOT BE PERFORMED. ISOLATE 911551 (1205056): THREE (3) OF THE FOUR (4) CARDS TESTED (2 CUSTOMER LOT CARDS AND 1 RANDOM LOT CARD) GAVE EXCELLENT IDENTIFICATIONS OF S. ENTERICA SSP ARIZONAE. HOWEVER, ONE RANDOM CARD GAVE A VERY GOOD ID OF E. COLI. API 20 E GAVE A GOOD ID (98.4%) OF S. ENTERICA SSP ARIZONAE, SO THE FINAL IDENTIFICATION IS S. ENTERICA SSP ARIZONAE. A COMPARISON OF CARD REACTION RESULTS FOR E. COLI AGAINST THE EXPECTED REACTION RESULTS FOR S. ENTERICA SSP ARIZONAE SHOWED TWO ATYPICAL NEGATIVE REACTIONS (MNT, PHOS) AND ONE ATYPICAL POSITIVE REACTION (ELLM) INDICATING AN ATYPICAL ISOLATE. THE VITEK 2 GP CARDS ARE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI AS SALMONELLA ENTERICA SSP DIARIZONAE FOR TWO URINE ISOLATES IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. REPEAT TESTING OBTAINED THE SAME RESULTS. AS THE CUSTOMER BELIEVED THE ORGANISM WAS NLF (NON-LACTOSE FERMENTING), THEY PERFORMED API® TESTING FOR ONE OF THE ISOLATES AND OBTAINED AN ORGANISM IDENTIFICATION OF ESCHERICHIA COLI. THE OTHER ISOLATE WAS SENT TO A REFERENCE LABORATORY WHERE IT WAS IDENTIFIED TO ESCHERICHIA COLI AS WELL (TEST METHOD NOT DISCLOSED BY THE CUSTOMER). THERE WAS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58950 VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410357403 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1