BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SYSTEM

    MDR report key: 14950991 · Received July 7, 2022

    Report

    Report Number
    1119779-2022-00961
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 2, 2022
    Report Date
    November 8, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT ALLEGES A FAILURE ON A MGIT 960 INSTRUMENT (P/N 445870, (B)(6)).THE DIFFERENCE IN MEASUREMENT CAUSED THE INSTRUMENT TO FLAG THE SPECIMENS AS POSITIVE NO SAMPLES OR PARTS WERE RETURNED FOR THIS COMPLAINT AND THUS, RETURNED SAMPLE ANALYSIS CANNOT BE COMPLETED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. THE ROOT CAUSE IS ATTRIBUTED TO CLEANING OF THE OPTICS DURING PREVENTATIVE MAINTENANCE THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. COMPLAINT HISTORY FOR RESULTS WAS REVIEWED FOR THE MONTH OF JUNE. THE UPPER CONTROL LIMIT WAS NOT BREACHED, AND TRENDS WERE NOT IDENTIFIED ASSOCIATED WITH THIS DEFECT. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. THIS COMPLAINT WILL BE INCLUDED IN THE PERIODIC TREND REVIEW. PER BALTRM-MGIT320_960-APH REVISION 5, THE HAZARD ASSOCIATED WITH THIS COMPLAINT IS FALSE POSITIVE, WHICH IS AN S3; REFERENCE ROW ID 2.1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE, BD BACTEC¿ MGIT¿ 960 SYSTEM, A FALSE POSITIVE OCCURRED. THIS A REPORT OF A SINGLE OCCURRENCE. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVES WERE OBSERVED." "...RESEARCH INSTITUTE HAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECT AND NO ERRONEOUS RESULTS WERE REPORTED TO THE HEALTHCARE PROVIDER. THE CUSTOMER NOTICED THE SUDDEN INCREASE IN POSITIVE RESULTS AND DID NOT COMMUNICATE THE INCORRECT INFORMATION FURTHER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE, BD BACTEC¿ MGIT¿ 960 SYSTEM, A FALSE POSITIVE OCCURRED. THIS A REPORT OF A SINGLE OCCURRENCE. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVES WERE OBSERVED." "...RESEARCH INSTITUTE HAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECT AND NO ERRONEOUS RESULTS WERE REPORTED TO THE HEALTHCARE PROVIDER. THE CUSTOMER NOTICED THE SUDDEN INCREASE IN POSITIVE RESULTS AND DID NOT COMMUNICATE THE INCORRECT INFORMATION FURTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865947 BD BACTEC¿ MGIT¿ 960 SYSTEM SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 00382904458706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown