BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 6999442 · Received November 3, 2017

    Report

    Report Number
    1950204-2017-00365
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Report Date
    April 16, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES HAD NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 GP TEST KIT. THE CUSTOMER REPORTED INITIALLY OBTAINING AN IDENTIFICATION OF GROUP B STREPTOCOCCI BUT UPON REPEAT TESTING, A LOW DISCRIMINATION CALL BETWEEN GROUP A AND GROUP B STREPTOCOCCI WAS OBTAINED. TESTING AT A REFERENCE LAB GAVE AN ID OF S. DYSGALACTIAE. STREP LATEX INDICATED GROUP A WHICH WOULD BE CONSISTENT WITH AN IDENTIFICATION OF S. DYSGALACTIAE SSP EQUISIMILIS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER STRAIN AND RAW DATA WERE NOT AVAILABLE FOR EVALUATION. NO SET UP INFORMATION WAS PROVIDED. ANALYSIS OF ATYPICAL REACTIONS WAS NOT POSSIBLE SINCE LAB REPORTS WERE NOT SUBMITTED. AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, STRAIN WITH DECREASED VIABILITY, USE OF NON-RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS, OR AN ATYPICAL STRAIN. HOWEVER, WITHOUT THE STRAIN, LAB REPORTS OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. VITEK 2 GP TEST KIT, LOT # 2420248203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 GP TEST KIT. THE CUSTOMER REPORTED THAT THE PATIENT HAD FOUR (4) POSITIVE BLOOD CULTURE BOTTLES STREP LATEX WAS PERFORMED, AND THE RESULT WAS GROUP A, WHICH WAS REPORTED TO THE PHYSICIAN. THE VITEK®2 GP CARD GAVE A RESULT OF GROUP B STREP. REPEAT TESTING WITH THE GP CARD GAVE LOW DISCRIMINATION. THE CUSTOMER BELIEVES THAT THE CORRECTED REPORT OF GROUP B STREP WAS REPORTED TO THE PHYSICIAN. THE ISOLATE WAS SENT TO ANOTHER LABORATORY FOR MALDI TESTING WITH A RESULT OF 50. THE RESULT OF 50 FOR GROUP A AND GROUP B STREP WAS GIVEN. THE ISOLATE WAS SENT TO THE STATE LABORATORY AND THE IDENTIFICATION WAS STREP DYSGALACTIAE. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781109 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX INC. 2420248203 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1