MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BACTEC MGIT; SYSTEM, BLOOD CULTURING

Catalog Number	441743
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bactec¿ mgit¿ 320 instrument, there were false negative results.There was no report of adverse patient impact.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E1.Initial reporter zip code:(b)(6).
Additional Manufacturer Narrative
Investigation summary: this customer reported having both false positive and false negative results.An fse went on site and cleaned the instrument/detector board, found the air filter to be damaged and reloaded the software.After these services, the instrument's operation was monitored for one protocol cycle and no issues were reported.The case was closed.The root cause of this complaint cannot be determined.There was no malfunction of the instrument reported and as such this is an unconfirmed complaint.Review of the device history record for instrument s/n (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the instrument has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no previous recent additional work orders were observed for the complaint failure mode reported.No samples were expected to be received as part of this complaint, and therefore no samples were available for returned material investigation.Bd quality will continue to closely monitor for trends associated with results related complaints.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
Event or Problem Description
It was reported while using the bd bactec¿ mgit¿ 320 instrument, there were false negative results.There was no report of adverse patient impact.

• Brand Name: BACTEC MGIT
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23301093
• Report Number: 1119779-2025-05127
• Device Sequence Number: 10027855
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K974883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 441743
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2014
• 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