BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 15999960 · Received December 16, 2022

    Report

    Report Number
    1119779-2022-01507
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    December 8, 2022
    Report Date
    December 23, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01507 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THE LAB TESTED ANAEROBIC VIAL HOWEVER CURVES LOOK POSITIVE BUT GAVE NEGATIVE RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANAEROBIC VIAL GAVE A NEGATIVE RESULT AND NO TESTS HAVE BEEN DONE ON IT AS WRITTEN IN LAB PROCEDURES. THE ANAEROBIC VIAL CURVE, WHICH LOOKS LIKE A POSITIVE CURVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THE LAB TESTED ANAEROBIC VIAL HOWEVER CURVES LOOK POSITIVE BUT GAVE NEGATIVE RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANAEROBIC VIAL GAVE A NEGATIVE RESULT AND NO TESTS HAVE BEEN DONE ON IT AS WRITTEN IN LAB PROCEDURES. THE ANAEROBIC VIAL CURVE, WHICH LOOKS LIKE A POSITIVE CURVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868406 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown