MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ FX40 INSTRUMENT; SYSTEM, BLOOD CULTURING

Catalog Number	442296
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec¿ fx40 instrument, there was a false negative result.No patient impact reported.
Additional Manufacturer Narrative
E1: initial reporter phone #: (b)(6).H3.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
H.6 investigation summary: a results failure was reported on a bactec fx40 instrument (p/n 442296, s/n (b)(6)).The customer reported that a negative bottle came out of the equipment.Bd remote services contacted customer and carried out a new test, bd remote services guided customer to took 1ml of the patient's sample and placed it in a vial with the same batch and in the same position on the equipment and the sample was positive within a few hours, the issue was resolved, the root cause is related to workflow.This is an unconfirmed failure of a bd product.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review for this instrument was completed and revealed two previous complaints (b)(4) related to results.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd bactec¿ fx40 instrument, there was a false negative result.No patient impact reported.

• Brand Name: BD BACTEC¿ FX40 INSTRUMENT
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18711623
• Report Number: 1119779-2024-00111
• Device Sequence Number: 20859998
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: (01)00382904422967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K915796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 442296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown