BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SYSTEM

    MDR report key: 12125872 · Received July 6, 2021

    Report

    Report Number
    1119779-2021-01139
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 14, 2021
    Report Date
    March 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904458706
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A FAILURE WAS REPORTED ON A MGIT 960 INSTRUMENT (P/N 445870, S/N (B)(6)). CUSTOMER INDICATED ABOUT THE FALSE NEGATIVES AND COLONIES ARE LODGED AT BOTTOM OF TUBES AND HARD TO BREAK UP AND DISLODGE. IF ANY INFORMATION IS PROVIDED IN THE FUTURE. THIS CASE WILL BE RE-OPENED AND RE-INVESTIGATED. THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. BD QUALITY DID NOT RECEIVE ANY RETURNED MATERIALS FOR REVIEW, HOWEVER, LOG FILES WERE COLLECTED AND REVIEWED. UPON REVIEW OF THE LOG FILES NO INSTRUMENT OR TEMPERATURE ERRORS WERE NOTED. REVIEW OF DEVICE HISTORY RECORD IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. SERVICE HISTORY FOR MG3736 REVEALED NO PREVIOUS COMPLAINTS RELATED TO THIS ISSUE. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A LJ SLATE WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DELAYED POSITIVES, FALSE NEGATIVES AND COLONIES ARE LODGED AT BOTTOM OF TUBES AND HARD TO BREAK UP AND DISLODGE. SEE REAGENT CASE (B)(4).

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A LJ SLATE WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DELAYED POSITIVES, FALSE NEGATIVES AND COLONIES ARE LODGED AT BOTTOM OF TUBES AND HARD TO BREAK UP AND DISLODGE. (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021048 BD BACTEC¿ MGIT¿ 960 SYSTEM SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 445870 00382904458706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown