BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION (GP ID) TEST KIT

    MDR report key: 5034266 · Received August 27, 2015

    Report

    Report Number
    1950204-2015-00020
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Report Date
    August 19, 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

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED FOR FIVE (5) ISOLATES RECEIVED FROM THE CUSTOMER. ISOLATES WERE SUB-CULTURED AND TESTING INCLUDED THE VITEK® 2 GP ID CARD LOT USED BY THE CUSTOMER, ALONG WITH TWO (2) CARDS FROM RANDOM GP ID LOTS. 16S SEQUENCING WAS ALSO PERFORMED, AS WAS VITEK® MS TESTING. FOR FOUR (4) OF THE FIVE (5) ISOLATES TESTED, THE GP ID CARDS PROVIDED EITHER A VERY GOOD ID (95%) OR AN EXCELLENT ID (99%) OF ENTEROCOCCUS GALLINARUM. WHEN 16S SEQUENCING WAS PERFORMED, ALL FOUR (4) ORGANISMS WERE IDENTIFIED AS ENTEROCOCCUS FAECIUM, WITH A 99% IDENTITY MATCH. ADDITIONALLY, VITEK MS IDENTIFIED ALL FOUR (4) ORGANISMS AS ENTEROCOCCUS FAECIUM, WITH A 99.9% CONFIDENCE LEVEL. FOR THE REMAINING ISOLATE, THE CUSTOMER GP ID CARD LOT PROVIDED A RESULT OF UNIDENTIFIED ORGANISM. ONE RANDOM CARD LOT GAVE A GOOD ID (89%) OF ENTEROCOCCUS FAECIUM, AND THE SECOND RANDOM LOT GAVE A VERY GOOD ID (93%) OF ENTEROCOCCUS FAECIUM. THE ISSUE IS NOT LOT-SPECIFIC. 16S SEQUENCING ALSO IDENTIFIED THE ORGANISM AS ENTEROCOCCUS FAECIUM, WITH A 93% IDENTITY MATCH, AND VITEK MS IDENTIFIED THE ORGANISM AS ENTEROCOCCUS FAECIUM, WITH A 99.9% CONFIDENCE LEVEL. THE OVERALL INVESTIGATION CONCLUDED THAT THE PATIENT ISOLATES ARE AN ATYPICAL STRAIN FOR VITEK 2 SYSTEM AST TESTING METHOD, WHICH IS COLORIMETRIC AND MEASURES ORGANISM GROWTH BEHAVIOR. BOTH 16S SEQUENCING AND VITEK MS USE GENETIC MEASUREMENT TECHNIQUES AND ARE MORE CONDUCIVE TO TESTING CERTAIN SLOWER-GROWTH ORGANISMS. REVIEW OF THE QC BATCH RECORDS INDICATES GP ID LOT 242357410 PASSED ALL INITIAL QC PERFORMANCE TESTING. THIS LOT PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) IS REPORTING A STRAIN OF ENTEROCOCCUS FAECIUM CURRENTLY IN THEIR HOSPITAL THAT IS PROVIDING INCONSISTENT IDENTIFICATION TEST RESULTS. CUSTOMER REPORTS A MISID OF E. FAECIUM AS E. GALLINARUM ON THE VITEK 2 XL IN ASSOCIATION WITH THE VITEK 2 GP ID CARD ((B)(4)). THE STRAIN WAS SENT TO A REFERENCE LAB AND CONFIRMED BY PCR TO BE A VANCOMYCIN RESISTANT ENTEROCOCCUS (VRE) STRAIN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION HAS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED FROM THE CUSTOMER. INTERNAL BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568073 VITEK® 2 GRAM-POSITIVE IDENTIFICATION (GP ID) TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 242357410

    Patients

    Seq Age Sex Outcome Treatment
    1