BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT BACTEC 9240 CR

    MDR report key: 11753746 · Received April 30, 2021

    Report

    Report Number
    1119779-2021-00743
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    K915796A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED A RESULTS ISSUE ON A BD BACTEC 9240 INSTRUMENT (P/N 445475, S/N (B)(6)). NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. BD REMOTE ASSISTANCE TALKED TO CUSTOMER ABOUT FALSE POSITIVES, AND IT WAS MORE LIKE A QUERY BECAUSE SOMEONE APPEARED FROM TIME TO TIME, TALKED ABOUT THE MOST COMMON CAUSES. REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED DUE TO THE AGE OF THE INSTRUMENT. SERVICE HISTORY REVIEW REVEALED NO PREVIOUS COMPLAINTS RELATED TO THIS ISSUE. BD QUALITY DID NOT RECEIVE PARTS FOR INVESTIGATION. THIS COMPLAINT IS AN UNCONFIRMED FAILURE OF BD PRODUCT. THE ROOT CAUSE IS 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 FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING INSTRUMENT BACTEC 9240 CR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: "THE CLIENT SAYS THEY HAVE A HIGH NUMBER OF POSITIVE VIALS: WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? YES; IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO CONFIRMATORY TEST WAS PERFORMED; ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO; WAS THERE ANY HARM TO THE PATIENT? NO. THE APPLICATION SPECIALIST CONFIRMED THE RATIO IS IN THE INSTRUMENT SPECIFICATIONS".

    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. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BACTEC¿ 9240, REMANUFACTURED CATALOG NUMBER 445569 WHICH HAS 510K NUMBER K915796A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING INSTRUMENT BACTEC 9240 CR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: "THE CLIENT SAYS THEY HAVE A HIGH NUMBER OF POSITIVE VIALS. WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO. CONFIRMATORY TEST WAS PERFORMED. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. WAS THERE ANY HARM TO THE PATIENT? NO. THE APPLICATION SPECIALIST CONFIRMED THE RATIO IS IN THE INSTRUMENT SPECIFICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653624 INSTRUMENT BACTEC 9240 CR SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1