BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 7052494 · Received November 22, 2017

    Report

    Report Number
    1950204-2017-00419
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Report Date
    April 17, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION FOR AN ATCC 27853 PSEUDOMONAS AERUGINOSA STRAIN IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT, (REF. 21341) LOT 2410252203. AN INVESTIGATION WAS PERFORMED. NO SET UP INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED DOING STERILITY CHECKS OF THEIR SALINE DAILY WITH NO ISSUES FOUND. THE FSE (FIELD SERVICE ENGINEER) CHECKED THE SYSTEM AND FOUND THAT THE VACUUM WAS LEAKING, CAUSING A LOW VACUUM. AFTER THE FSE FIXED THIS PROBLEM, THE CUSTOMER REPORTED THERE WERE NO MORE IDENTIFICATION ISSUES. TWO LAB REPORTS WERE SUBMITTED WITH BOTH SHOWING AN ACCEPTABLE IDENTIFICATION OF B. CEPACIA GROUP, WITH ONE LAB REPORT SHOWING EIGHT (8) ATYPICAL POSITIVE REACTIONS (SAC, DTAG, PLE, DTRE, LARL, DCEL, DSOR, PHOS) AND THE OTHER SHOWING SEVEN (7) ATYPICAL POSITIVE REACTIONS (GROUP WITH ONE LAB REPORT SHOWING 8 EIGHT (8) ATYPICAL POSITIVE REACTIONS (SAC, DTAG, PLE, DTRE, LARL, DSOR, PHOS) FOR AN IDENTIFICATION OF P. AERUGINOSA ACCORDING TO THE GN KNOWLEDGE BASE. 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. BASED ON THE INFORMATION PROVIDED IT SEEMS LIKELY THAT THE IDENTIFICATION ISSUE WAS CAUSED BY THE LOW VACUUM. HOWEVER WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. THE P. AERUGINOSA ATCC 27853 IS NOT A QC STRAIN FOR THE GN CARD. THE VITEK 2 GN LOT # 2410252203 MET FINAL QC RELEASE CRITERIA AND PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR AN ATCC 27853 PSEUDOMONAS AERUGINOSA STRAIN IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT, (REF. 21341) LOT 2410252203. VITEK® 2 FAILED TO IDENTIFY THE ORGANISM, AND PROVIDED BURKHOLDERIA SSP AS A POTENTIAL IDENTIFICATION. A FIELD SERVICE ENGINEER (FSE) CHECKED THE VITEK® 2 SYSTEM AND FOUND THAT THERE WAS LOW VACUUM DUE TO VACUUM LEAKING. PER THE CUSTOMER, NO PATIENT RESULTS WERE AFFECTED. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS WORKING AS EXPECTED AFTER FSE INTERVENTION. THE CUSTOMER REPORTED THAT NO PATIENT RESULTS WERE AFFECTED; THEREFORE, THERE WAS NO PATIENT HARM. THERE WAS NO PATIENT ASSOCIATED WITH THIS QC STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832487 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410252203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1