BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 6945580 · Received October 12, 2017

    Report

    Report Number
    1950204-2017-00335
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Report Date
    November 10, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES HAD REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A STREPTOCOCCUS AGALACTIAE API SURVEY SAMPLE AS STREPTOCOCCUS THORALTENSIS IN ASSOCIATION WITH THE VITEK® 2 GP ID TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE STRAIN WAS NOT AVAILABLE TO SUBMIT FOR INVESTIGATION. THE CUSTOMER REPORTED SETTING UP THE ISOLATE FROM BBL TSA WITH 5% SHEEP BLOOD AND INCUBATING THE STRAIN IN 5% CO2 AT 36C FOR 18-24HRS. TWO LAB REPORTS WERE SUBMITTED. THE FIRST SHOWED A GOOD IDENTIFICATION OF S. THORALTENSIS WITH 4 ATYPICAL POSITIVE REACTIONS (AMY, DRAF, DXYL, PUL) FOR AN IDENTIFICATION OF S. AGALACTIAE ACCORDING TO THE GP KNOWLEDGE BASE. THE SECOND LAB REPORT SHOWED A LOW DISCRIMINATION IDENTIFICATION BETWEEN S. AGALACTIAE AND S. DYSGALACTIAE SSP EQUISIMILIS. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS OR AN ATYPICAL STRAIN. HOWEVER, WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MIS-IDENTIFICATION. GP LOT# 2420029103 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED A MISIDENTIFICATION OF A STREPTOCOCCUS AGALACTIAE API SURVEY SAMPLE, AS STREPTOCOCCUS THORALTENSIS IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. THE CUSTOMER REPORTED THAT THE IDENTIFICATION FROM THE FIRST SURVEY SWAB WAS REPORTED AS STREPTOCOCCUS THORALTENSIS. AFTER LEARNING THE EXPECTED RESULT WAS STREPTOCOCCUS AGALACTIAE, THE CUSTOMER TESTED THE SECOND SWAB AND THE RESULT WAS STREPTOCOCCUS AGALACTIAE LOW DISCRIMINATION. BOTH TEST RUNS WERE POSITIVE FOR D-AMYGDALIN, PULLULAN, AND D-RAFFINOSE WHEN THEY SHOULD HAVE BEEN NEGATIVE FOR THE EXPECTED RESULT. THERE WAS NO PATIENT INVOLVEMENT AS THIS EVENT WAS FOR A SURVEY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724112 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST CARD LQL BIOMERIEUX, INC 2420029103

    Patients

    Seq Age Sex Outcome Treatment
    1