BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED

    MDR report key: 14272876 · Received May 4, 2022

    Report

    Report Number
    1119779-2022-00642
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 10, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413866
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6. INVESTIGATION SUMMARY: A COMPLAINT OF "DRAWER C ROWS J/K UNUSABLE/ FALSE POSITIVES" WAS RECEIVED AGAINST INSTRUMENT BOTTOM BACTEC FX, MATERIAL NO: 441386, SERIAL NO: (B)(6). FIELD SERVICE ENGINEER WAS DISPATCHED AND RACK WAS REPLACED TO RESOLVE THE ISSUE. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE OF FALSE POSITIVES IS NOT KNOWN. 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. DEVICE WAS INSTALLED ON 5/27/2015. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. SERVICE HISTORY REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. COMPLAINTS FOR ¿RESULTS¿ ISSUES WHICH INCLUDED " FALSE POSITIVES " COMPLAINTS ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 2022. THE UPPER CONTROL LIMIT WAS NOT BREACHED. QUALITY WILL CONTINUE TO MONITOR THE " FALSE POSITIVES ¿COMPLAINTS. NO TRENDS WERE IDENTIFIED. PER BALTRMBACTECINSTRAPH REVISION 15, THE ERROR RELATED TO THIS COMPLAINT IS CONSIDERED USER INCONVENIENCE, WHICH IS AN S1; REFERENCE ROW ID 1.2C. NO NEW RISKS OR HAZARDS WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED, FALSE POSITIVE RESULTS WERE ACQUIRED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX441386 / DRAWER C ROWS J/K UNUSABLE. CUSTOMER HAD THIS ISSUE WITH DRAWER C ROWS J/K GOING UNUSABLE. THEY MOVED THE VIALS IN THESE ROWS RIGHT AWAY, BUT SHORTLY AFTER THEY MOVED THE VIALS 4 TURNED POSITIVE SHORTLY AFTER. 3 AEROB BOTTLES AND 1 ANAEROB. CUSTOMER DID A GRAM STAIN AND FOUND NO GROWTH. THEY REINSERTED THE VIALS TO COMPLETE THE PROTOCOL. THESE FALSE POSITIVE RESULTS WERE NOT REPORTED OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED, FALSE POSITIVE RESULTS WERE ACQUIRED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FX441386 / DRAWER C ROWS J/K UNUSABLE. CUSTOMER HAD THIS ISSUE WITH DRAWER C ROWS J/K GOING UNUSABLE. THEY MOVED THE VIALS IN THESE ROWS RIGHT AWAY, BUT SHORTLY AFTER THEY MOVED THE VIALS 4 TURNED POSITIVE SHORTLY AFTER. 3 AEROBIC BOTTLES AND 1 ANAEROBIC. CUSTOMER DID A GRAM STAIN AND FOUND NO GROWTH. THEY REINSERTED THE VIALS TO COMPLETE THE PROTOCOL. THESE FALSE POSITIVE RESULTS WERE NOT REPORTED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500967 BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441386 NA 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown