BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 6443577 · Received March 29, 2017

    Report

    Report Number
    1950204-2017-00101
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Report Date
    June 23, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF STREPTOCOCCUS PNEUMONIAE AS STREPTOCOCCUS SUIS II, IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE ISOLATE WAS GROWN ON BLOOD AGAR WITH 5% (B)(4) (EITHER HOMEMADE OR FROM OXOID) AND INCUBATED IN 5% CO2 FOR 24 HOURS BEFORE TESTING. TWO (2) LAB REPORTS WERE SUBMITTED. LAB REPORT (B)(6) 2017: A VERY GOOD IDENTIFICATION OF STREP. SUIS II WAS OBTAINED FROM THE VITEK® 2 GP CARD. THERE WERE FOUR (4) ATYPICAL POSITIVE REACTIONS (ADH1, NOVO, SAL, ADH2S) FOR AN IDENTIFICATION OF STREP. PNEUMONIAE ACCORDING TO THE GP KNOWLEDGE BASE. LAB REPORT (B)(6) 2017: A VERY GOOD IDENTIFICATION OF STREP. SUIS II WAS OBTAINED FROM THE VITEK® 2GP CARD. THERE WERE FIVE (5) ATYPICAL POSITIVE REACTIONS (ADH1, NOVO, SAL, PUL, ADH2S) FOR AN IDENTIFICATION OF STREP. PNEUMONIAE ACCORDING TO THE GP KNOWLEDGE BASE. RAW DATA FROM ONE (1) VITEK® 2 GP CARD WAS SUBMITTED FROM LOT #2420161103, WHICH GAVE A VERY GOOD IDENTIFICATION OF STREP. SUIS II. THERE WERE FIVE (5) ATYPICAL REACTIONS (ADH1, NOVO, PUL, SAL, ADH2S) FOR AN IDENTIFICATION OF STREP. PNEUMONIAE ACCORDING TO THE GP KNOWLEDGE BASE. REVIEW OF THE GROWTH CURVES FOR THE FIVE (5) ATYPICAL WELLS SHOWED STRONG, POSITIVE GROWTH IN EACH WELL. 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. ON 24MAY2017 IND - GP LOT# 2420161103 MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES ON THE INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF STREPTOCOCCUS PNEUMONIAE AS STREPTOCOCCUS SUIS II, IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. THE CUSTOMER TESTED THE ISOLATE TWICE WITH VITEK® 2 GP AND THE RESULT WAS STREPTOCOCCUS SUIS II. THE CUSTOMER SUSPECTED IT WAS STREPTOCOCCUS PNEUMONIAE, SO THE ISOLATE WAS SENT TO ANOTHER HOSPITAL FOR TESTING WITH THE MALDI-BIOTYPER SYSTEM. THE RESULT OBTAINED WAS STREPTOCOCCUS PNEUMONIAE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. THE ISOLATE WAS NOT AVAILABLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225600 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST CARD LQL BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1