BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 GP TEST KIT

    MDR report key: 7679674 · Received July 11, 2018

    Report

    Report Number
    1950204-2018-00252
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Report Date
    September 4, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED DUE TO A CUSTOMER REPORTING A MISIDENTIFICATION OF STREPTOCOCCUS SANGUIS (IDENTIFICATION FROM REFERENCE LAB) AS PEDIOCOCCUS PENTOSACEUS WITH THE VITEK® 2 GP ID CARD. NOTE: S. SANGUIS IS THE FORMER NAME FOR S. SANGUINIS WHICH IS THE NOMENCLATURE RECOGNIZED IN THE VITEK 2 GP KNOWLEDGE BASE. THE CUSTOMER SUBMITTED THEIR STRAIN FOR EVALUATION. THE SUBMITTED STRAIN WAS SUBCULTURED TO TSAB AND INCUBATED AT 37°C IN CO2 ATMOSPHERE. THE VITEK 2 GP ID CARD TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH CARDS FROM THE CUSTOMER LOT (2420617403) AND A RANDOM LOT (2420561103) IN DUPLICATE. ADDITIONAL TESTING INCLUDED VITEK MS AND API 20 STREP KIT. 911634 : TWO GP CARDS TESTED RESULTED IN EXCELLENT IDENTIFICATIONS OF STREPTOCOCCUS ANGINOSUS AND THE REMAINING TWO GP CARDS RESULTED IN LOW DISCRIMINATION IDENTIFICATIONS STREPTOCOCCUS ANGINOSUS / STREPTOCOCCUS GORDONII. VITEK MS RESULTED IN AN IDENTIFICATION OF S. ANGINOSUS WITH A 99.9% CONFIDENCE VALUE AND API 20 STREP KIT RESULTED IN A 91.1 % IDENTIFICATION OF S. ANGINOSUS. THE FINAL IDENTIFICATION OF THIS STRAIN IS S. ANGINOSUS. A REVIEW OF THE CUSTOMER'S P. PENTOSACEUS REACTIONS DEMONSTRATED EIGHT ATYPICAL NEGATIVE REACTIONS ( AMY, APPA, PHOS, TYRA, POLYB, LAC, NOVO, ADH2S) FOR AN IDENTIFICATION OF S. ANGINOSUS ACCORDING TO THE GP KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. THE VITEK 2 GP ID CARDS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 GP TEST KIT (REFERENCE 21342). THE CUSTOMER REPORTED HAVING A PATIENT WITH BLOOD CULTURE ISOLATE THAT IDENTIFIED TWICE AS PEDIOCOCCUS. THE ISOLATE WAS SENT OUT TO A REFERENCE LABORATORY AND THE IDENTIFICATION FOR THE ISOLATE IS STREPTOCOCCUS SANGUINIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519666 VITEK®2 GP TEST KIT VITEK®2 GP TEST KIT LQL BIOMERIEUX, INC 2420617403 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1