BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SYSTEM

    MDR report key: 17467481 · Received August 6, 2023

    Report

    Report Number
    1119779-2023-00840
    Event Type
    Malfunction
    Date Received
    August 6, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904458706
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00840 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SYSTEM, THERE WAS ONE FALSE POSITIVE RESULT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVE IN COLUMN M OF COLUMN C."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SYSTEM, THERE WAS ONE FALSE POSITIVE RESULT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVE IN COLUMN M OF COLUMN C."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310918 BD BACTEC¿ MGIT¿ 960 SYSTEM SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 00382904458706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown