BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 5083535 · Received September 17, 2015

    Report

    Report Number
    1950204-2015-00035
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Report Date
    September 8, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE PATIENT ISOLATE, THE ISOLATE WAS SUBCULTURED AND TESTING INCLUDED FOUR (4) CARDS OF THE CUSTOMER LOT OF VITEK® 2 GP ID CARDS, FOUR (4) CARDS FROM A RANDOM LOT, THE API20® STREP AND THE VITEK® MS. VERY GOOD IDENTIFICATION OR EXCELLENT IDENTIFICATION CALLS OF STREPTOCOCCUS PYOGENES WERE OBTAINED FROM THE CUSTOMER'S LOT. ONE (1) VERY GOOD IDENTIFICATION CALL OF STREPTOCOCCUS PYOGENES AND THREE (3) LOW DISCRIMINATION CALLS OF STREPTOCOCCUS DYSGALACTIAE SSP DYSGALACTIAE / STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS / STREPTOCOCCUS PYOGENES WERE OBTAINED FROM THE RANDOM LOT. THE API® 20 STREP GAVE AN IDENTIFICATION OF STREPTOCOCCUS PYOGENES WITH A 99.2% CONFIDENCE LEVEL AND THE VITEK® MS GAVE AN IDENTIFICATION OF STREPTOCOCCUS PYOGENES WITH A 99.9% CONFIDENCE LEVEL. THE LOW DISCRIMINATION RESULTS OBTAINED BY THE CUSTOMER AND IN-HOUSE ARE ACCEPTABLE DUE TO STREPTOCOCCUS PYOGENES BEING ONE OF THE CHOICES. THE VITEK® 2 GP ID CARDS ARE PERFORMING AS EXPECTED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT ((B)(4), LOT 242352010). THE VITEK 2 GP ID TEST KIT REPORTED THE ORGANISM AS STREPTOCOCCUS PSEUDOPORCINUS. REPEAT TESTING PROVIDED A LOW DISCRIMINATION RESULT THAT INCLUDED: STREPTOCOCCUS DYSGALACTIAE SSP DYSGALACTIAE, STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS, STREPTOCOCCUS PYOGENES. THE PATIENT ISOLATE WAS ALSO SENT TO PHL (EXTERNAL LAB) FOR CONFIRMATORY TESTING. A LATEX GROUPING WITH CONFIRMATION FROM MALDI TOF WERE PERFORMED; A RESULT OF STREPTOCOCCUS PYOGENES WAS OBTAINED. IT WAS NOTED THAT THE ORGANISM IS SLOW GROWING, LEADING TO DIFFICULTY WITH REGARD TO SUCCESSFUL IDENTIFICATION AND SUSCEPTIBILITY TESTING. THE VITEK 2 GP ID RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN AND WERE NOT USED IN TREATMENT DECISIONS. THE MALDI TOF STREPTOCOCCUS PYOGENES RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMɒIEUX FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617351 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 242352010

    Patients

    Seq Age Sex Outcome Treatment
    1