BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE BLOOD CULTURE-GRAM NEGATIVE NUCLEIC ACID TEST KIT

    MDR report key: 12911560 · Received December 1, 2021

    Report

    Report Number
    3006028115-2021-00009
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 1, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    PEN
    UDI-DI
    00840487101599
    PMA / PMN Number
    K132843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER HAD REPORTED 'NO CALL' INTERNAL CONTROL ERROR ON THE VERIGENE BC-GN ASSAY. THE 'NO CALL' ERROR HAD OCCURRED DURING QUALITY CONTROL (QC) TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT HAD OCCURRED. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804641 VERIGENE BLOOD CULTURE-GRAM NEGATIVE NUCLEIC ACID TEST KIT VERIGENE BC-GN PEN LUMINEX CORPORATION 20-006-021 102221021A 00840487101599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown