BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CTGCTV2

    MDR report key: 20902537 · Received December 11, 2024

    Report

    Report Number
    3007420875-2024-00180
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    October 23, 2024
    Report Date
    March 18, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    UDI-DI
    00382904439798
    PMA / PMN Number
    K210585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP . A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE PREVIOUS MFR REPORT # 3007420875-2024-00180 WAS SUBMITTED AGAINST WRONG PRODUCT. THIS REPORT IS TO BE REPLACE BY MFR REPORT # 1119779-2025-00272.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 ON BD MAX INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING THE REAGENTS AND INSTRUMENT, IT WAS VISIBLE THAT A "BLOODY SLIME STRING" FROM A SAMPLE WAS DRAGGED OVER THE PROCESS AREA AND CONTAMINATED THE SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 ON BD MAX INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING THE REAGENTS AND INSTRUMENT, IT WAS VISIBLE THAT A "BLOODY SLIME STRING" FROM A SAMPLE WAS DRAGGED OVER THE PROCESS AREA AND CONTAMINATED THE SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573616 BD CTGCTV2 MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD, KIT, NUCLEIC ACID LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 00382904439798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown