BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT BACTEC 9240 CR

    MDR report key: 11916821 · Received June 1, 2021

    Report

    Report Number
    1119779-2021-00933
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 5, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    K915796A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED AN ISSUE ON A BD BACTEC 9240 CR (P/N 445475, S/N (B)(6). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES AND REPORTED DIRTY AIR FILTERS. A BD REMOTE ASSISTANCE COMMUNICATED WITH THE CUSTOMER AND CONFIRMED THAT FALSE POSITIVES ARE CLEARED AFTER CLEANING THE AIR FILTER. THIS IS AN UNCONFIRMED FAILURE OF THE BD PRODUCT. DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE PRODUCT IS END OF LIFE. THE CONFIGURATION OF THE DEVICE HAS CHANGED DURING SERVICES AND PMS AND THUS, DHR REVIEW IS NOT REQUIRED. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS DIRTY AIR FILTERS. NO NEW RISKS OR HAZARDS. NO NEW TRENDS AFTER TAKING THE UNCONFIRMED COMPLAINTS INTO ACCOUNT. CAPA (CORRECTIVE AND PREVENTIVE ACTION) IS NOT REQUIRED FOR UNCONFIRMED COMPLAINTS. H3 OTHER TEXT : SEE H10.

    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. 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: " THE SAMPLES ARE POSITIVE AS SOON AS THEY ARE INSERTED IN THE EQUIPMENT, FREEZING AROUND 40 TO 50 FALSE POSITIVES."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6); INITIAL REPORTER ADDRESS: (B)(6). 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 U.S. AND NOT SOLD IN THE U.S. 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. 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: "THE SAMPLES ARE POSITIVE AS SOON AS THEY ARE INSERTED IN THE EQUIPMENT, FREEZING AROUND 40 TO 50 FALSE POSITIVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812271 INSTRUMENT BACTEC 9240 CR SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown