BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 6000078 · Received October 5, 2016

    Report

    Report Number
    1950204-2016-00143
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Report Date
    September 6, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE CUSTOMER'S CAP STRAIN WAS NOT SUBMITTED SO THE INTERNAL LYOPHILIZED CAP SAMPLE WAS RECONSTITUTED AND TESTED. THE RECONSTITUTED SAMPLE WAS SUBCULTURED, AND VITEK® 2 GP ID TESTING INCLUDED TWO CARDS FROM THE CUSTOMER LOT AND TWO CARDS EACH FROM THREE RANDOM LOTS (TOTAL OF EIGHT CARDS). EXCELLENT IDENTIFICATION OF PEDIOCOCCUS ACIDILACTICI WERE OBTAINED ON FOUR CARDS FROM RANDOM LOTS. THE TWO CARDS FROM THE CUSTOMER'S LOT AND TWO CARDS FROM RANDOM LOTS RESULTED IN LOW DISCRIMINATION CALLS OF PEDIOCOCCUS ACIDILACTICI/PEDIOCOCCUS PENTOSACEUS. THE LOW DISCRIMINATION IDENTIFICATION RESULTS ARE ACCEPTABLE SINCE THEY INCLUDE THE EXPECTED RESULT OF PEDIOCOCCUS ACIDILACTICI. THESE SPECIES ARE CLOSELY RELATED AND REVIEW OF THE EXPECTED DATA FOR PEDIOCOCCUS ACIDILACTICI DEMONSTRATED NO ATYPICAL REACTIONS. THE INVESTIGATION CONCLUDED THE VITEK® 2 GP ID IS PERFORMING AS EXPECTED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAP SURVEY ORGANISM PEDIOCOCCUS ACIDILACTICI AS PEDIOCOCCUS PENTOSACEUS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. REPEAT TESTING PROVIDED THE SAME RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE CAP SURVEY SAMPLE. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652634 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 242395010

    Patients

    Seq Age Sex Outcome Treatment
    1