BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ STAPHSR

    MDR report key: 17778330 · Received September 19, 2023

    Report

    Report Number
    1119779-2023-01018
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 24, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    NQX
    UDI-DI
    00382904434199
    PMA / PMN Number
    K132822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER E-MAIL: (B)(6). H.3. 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 OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-01018 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ STAPHSR THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 SAMPLES THAT CHANNELS NUC (530/565 NM) AND MECA/MECC (585/630 NM) WERE POSITIVE, BUT MREJ (475/520 NM) REMAINED NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ STAPH THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 SAMPLES THAT CHANNELS NUC (530/565 NM) AND MECA/MECC (585/630 NM) WERE POSITIVE, BUT MREJ (475/520 NM) REMAINED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801795 BD MAX¿ STAPHSR SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC NQX BECTON DICKINSON & CO. (SPARKS) 2270650 00382904434199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown