BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 GP ID TEST KIT

    MDR report key: 6096957 · Received November 11, 2016

    Report

    Report Number
    1950204-2016-00175
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    October 13, 2016
    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

    A CUSTOMER FROM (B)(6) REPORTED A DISCREPANCY WITH A PROFICIENCY SAMPLE RESULT ASSOCIATED WITH THE VITEK®2 AST-GP67 CARD. THE SAMPLE ORGANISM ENTEROCOCCUS FAECIUM WAS IDENTIFIED AS ENTEROCOCCUS DURANS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE SUBMITTED ISOLATE WAS SUBCULTURED AND TESTING INCLUDED TWO (2) VITEK® 2 AST-GP CARDS FROM THE CUSTOMER'S LOT, TWO (2) CARDS FROM A RANDOM LOT, API 20 STREP KIT AND VITEK® MS. THE FOUR (4) VITEK® 2 AST-GP CARDS TESTED RESULTED IN VERY GOOD IDENTIFICATIONS OF ENTEROCOCCUS DURANS. EXPER/ESSAY 5491-60. THE API STREP TESTING RESULTED IN A VERY GOOD IDENTIFICATION TO THE GENUS OF ENTEROCOCCUS DURANS. VITEK® MS IDENTIFIED THE ISOLATE AS ENTEROCOCCUS FAECIUM. A REVIEW OF THE CUSTOMER'S ENTEROCOCCUS DURANS DATA AGAINST THE EXPECTED REACTIONS FOR ENTEROCOCCUS FAECIUM DEMONSTRATED THREE (3) ATYPICAL NEGATIVE REACTIONS (BGAL, DMAN, AND DTRE). A REVIEW OF THE INTERNAL GP TESTING OF THE ISOLATE DEMONSTRATED TWO (2) ATYPICAL NEGATIVE REACTIONS (DMAN AND DTRE) CONTRIBUTING TO THE MISIDENTIFICATION. ROOT CAUSE: ATYPICAL STRAIN. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. THE MOST RECENT QUARTERLY TREND REVIEW DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED A DISCREPANCY WITH A PROFICIENCY SAMPLE RESULT ASSOCIATED WITH THE VITEK®2 AST-GP67 CARD. THE SAMPLE ORGANISM ENTEROCOCCUS FAECIUM WAS IDENTIFIED AS ENTEROCOCCUS DURANS. THE TEST WAS REPEATED WITH THE PROFICIENCY SAMPLE, ON TWO (2) VITEK®2 SYSTEMS, WHICH CONFIRMED ENTEROCOCCUS DURANS. THE CUSTOMER STATED THEY USE OXOID BLOOD AGAR MEDIA AND INCUBATE 24 HOURS. THE PROFICIENCY SAMPLE TEST REPORTS AND THE ISOLATE WERE REQUESTED FROM THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT A PATIENT WAS DIRECTLY ASSOCIATED WITH THE PROFICIENCY SAMPLE RESULT. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746501 VITEK 2 GP ID TEST KIT VITEK 2 GP ID CARD LQL BIOMERIEUX, INC 242393320

    Patients

    Seq Age Sex Outcome Treatment
    1