BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE BC-GP UTILITY REAGENT KIT

    MDR report key: 17940622 · Received October 16, 2023

    Report

    Report Number
    3006028115-2023-00002
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 16, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    PAM
    UDI-DI
    00840487101629
    PMA / PMN Number
    K122514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THAT LOW VOLUMES OF THE LABIASE ENZYME COULD RESULT IN FALSE-NEGATIVE RESULTS, IMPACTING E. FAECALIS, E. FAECIUM, VANA, AND VANB. PER CRA-13010, A SINGLE FALSE NEGATIVE EFC/EFL DUE TO DEVICE MALFUNCTION OR MISUSE WOULD BE REPORTABLE AS A "SERIOUS INJURY." IN GENERAL, ENTEROCOCCI ARE MORE LIKELY TO BE RESISTANT TO BETA-LACTAMS AND FIRST-LINE ANTIMICROBIALS THAN STAPH INFECTIONS AND MORE LIKELY TO BE RESISTANT TO VANCOMYCIN THAN OTHER BACTERIAL SPECIES. MOREOVER, FALSE NEGATIVE EFL/EFC WOULD PRECLUDE DETERMINATION OF VANA OR VANB MEDIATED RESISTANCE. AS SUCH, THE RISK TO HEALTH IS GREATER BECAUSE INADEQUATE TREATMENT IS MORE LIKELY IF VRE CANNOT BE IDENTIFIED, AND CLINICIANS WOULD LIKELY NOT ADMINISTER NEWER ANTIBIOTICS SUCH AS SUCH AS LINEZOLID, QUINUPRISTIN/DALFOPRISTIN, DAPTOMYCIN, TELAVANCIN, DALBAVANCIN, AND TIGECYCLINE.

    Description of Event or Problem · 0

    (B)(4). UPON FURTHER INSPECTION, LOWER VOLUMES OF THE LABIASE ENZYME WERE OBSERVED IN WELL 2 OF THE UTILITY TRAY, AS SHOWN IN FIGURE 1 (ATTACHED). ONE OF THE TRAYS HAD A VISIBLY LOWER VOLUME OF REAGENT IN WELL 2, COMPARED TO THE PRODUCT SPECIFICATION OF 100±10 MICROLITERS. NC-04966 AND HRA-23-0033 WERE INITIATED FOR THE NONCONFORMING MATERIAL. THERE WERE NO FALSE RESULTS OBSERVED DURING FINAL PRODUCT TESTING FOR LOT 062123018C. THE LABIASE ENZYME IN THE VERIGENE BC-GP ASSAY IS AN ENZYME PREPARATION USEFUL FOR THE LYSIS OF ENTEROCOCCUS BACTERIA. WITHIN NC-04966, IT WAS DETERMINED THAT LOW VOLUMES OF THE LABIASE ENZYME COULD RESULT IN FALSE-NEGATIVE RESULTS, IMPACTING E. FAECALIS, E. FAECIUM, VANA, AND VANB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631242 VERIGENE BC-GP UTILITY REAGENT KIT VERIGENE BC-GP UTILITY REAGENT KIT PAM LUMINEX CORPORATION 062123018C 00840487101629

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown