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

Catalog Number	441385
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bactec¿ fx, instrument top, packaged that there was a false negative.No patient impact.
Additional Manufacturer Narrative
H.6 investigation summary.Customer contacted bd support regarding their bactec fx top 441385 sn (b)(6) alleging false results.The customer stated their fx sent a negative result on (b)(6) 2024, and then flagged positive on (b)(6).Bd support pulled log files for analysis and found that the sample had flagged negative at the end of its 5 day protocol, and the sample was left in the drawer, which was then flagged as positive the next morning.The fx system will continue to monitor and read vials upon completion of protocol, and any interference or changes to the samples may have the possibility to cause a false result reading.Bd specifies protocol length for samples for this reason, and as this false result occurred outside of the recommended protocol time, this complaint is unconfirmed as a failure of a bd instrument.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 showed one prior complaint for false positives that was the result of interference from a prior servicing.Samples in the form of log files showed the sample flagged positive outside of the protocol length and no instrument issues were present.Review of risk management files confirms there are no new or modified risks associated with this failure mode.
Event or Problem Description
It was reported that while using bd bactec¿ fx, instrument top, packaged that there was a false negative.No patient impact.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED
• 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: 19010580
• Report Number: 1119779-2024-00237
• Device Sequence Number: 11714661
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/05/2024

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: 441385
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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