BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP ID TEST KIT

    MDR report key: 6031319 · Received October 14, 2016

    Report

    Report Number
    1950204-2016-00148
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE MIS-IDENTIFICATION EVENT WAS INVESTIGATED BY BIOMERIEUX. THE RECONSTITUTED CAP SURVEY SAMPLE WAS TESTED ON 2 CARDS FROM 4 DIFFERENT LOTS. EXCELLENT IDENTIFICATIONS OF PEDIOCOCCUS ACIDILACTICI WERE OBTAINED ON FOUR CARDS AND LOW DISCRIMINATION CALLS OF PEDIOCOCCUS ACIDILACTICI/PEDIOCOCCUS PENTOSACEUS WERE OBTAINED ON THE REMAINING FOUR CARDS. THESE SPECIES ARE CLOSELY RELATED AND REVIEW OF THE EXPECTED DATA FOR PEDIOCOCCUS ACIDILACTICI DEMONSTRATED NO ATYPICAL REACTIONS. BASED ON THE RESULTS OF THE INVESTIGATION, THE PRODUCT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER NOTIFIED BIOMERIEUX THAT THEY HAD A MIS-IDENTIFICATION WHEN USING THE VITEK 2 GP ID TEST KIT. A CAP SURVEY PROFICIENCY SAMPLE WAS IDENTIFIED BY THE VITEK 2 TESK KIT AS PEDIOCOCCUS PENTOSACEUS. THE ACTUAL RESULT SHOULD HAVE BEEN PEDIOCOCCUS ACIDILACTICL. SINCE THIS IS A PROFICIENCY SAMPLE AND NOT A PATIENT SAMPLE, NO INJURY OR DEATH ASSOCIATED WITH THIS EVENT. AN INVESTIGATION HAS BEEN CONDUCTED BY BIOMERIEUX FOR EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681794 VITEK® 2 GP ID TEST KIT VITEK® 2 GP ID TEST KIT LQL BIOMERIEUX, INC 242397440

    Patients

    Seq Age Sex Outcome Treatment
    1