BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT BACTEC 9240 CR

    MDR report key: 12178038 · Received July 15, 2021

    Report

    Report Number
    1119779-2021-01177
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    April 19, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    K915796A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT OF "FALSE POSITIVES" WAS RECEIVED AGAINST INSTRUMENT BACTEC 9240 CR , MATERIAL NO: 445475, SERIAL NO: UNKNOWN. THE COMPLAINT IS NOT CONFIRMED AS A FAILURE OF BD PRODUCT BECAUSE OF THE LACK OF INFORMATION. THE ROOT CAUSE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED. DHR REVIEW CANNOT BE PERFORMED FOR THIS COMPLAINT AS THE SERIAL NUMBER FOR THE PRODUCT WAS NOT PROVIDED. SERVICE HISTORY REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. NO NEW RISKS, TRENDS, OR HAZARDS WERE IDENTIFIED. BD WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING INSTRUMENT BACTEC 9240 CR 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IDENTIFY FALSE POSITIVE TRENDS ."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IDENTIFY FALSE POSITIVE TRENDS ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074304 INSTRUMENT BACTEC 9240 CR SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown