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	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that when using the bd bactec¿ fx40 instrument, there were two anaerobic bottles for the same patient resulted in false negative.No patient treatment was impacted as results were corroborated by aerobic culture bottles and treatment was based on those.
Event or Problem Description
It was reported that when using the bd bactec¿ fx40 instrument, there were two anaerobic bottles for the same patient resulted in false negative.No patient treatment was impacted as results were corroborated by aerobic culture bottles and treatment was based on those.
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 two bottles were detected as negative by the unit, customer noted that both were from the same patient and collected on the same day.Bd remote services contacted customer and did a troubleshooting, customer reported that no alerts nor error messages were displayed, and no power outage was detected during the incubation of the bottles.Additionally, the logfiles were reviewed and customer was advised to allow the bottles to be flag as negatives by the instrument.Customer noted that the anaerobic bottles were removed on the 4th day of incubation and bd remote services advised they should allow the instrument to flag negative bottles before removal, the instrument is working within specifications and no errors were detected.On a follow up call, aside from the two vials, there were no other occurrences of false negatives and no grinding/loud noise on the instrument.The root cause is unknown.This is an unconfirmed failure of a bd product.Physical samples were not received by quality for investigation however, log files were received and reviewed.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 no previous complaints 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.

• 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: 18911494
• Report Number: 1119779-2024-00207
• Device Sequence Number: 17832738
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: (01)00382904422967
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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