MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 320 INSTRUMENT; 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	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bactec¿ mgit¿ 320 instrument, there was a false positive result.There was no report of adverse impact to patient.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Catalog #441743, s/n (b)(6): the customer is reporting there is a false positive reported from the instrument.Through remote assistance, information was shared regarding growth units versus threshold positivity.The customer discovered the original sample had a high bacterial load so the analysis made sense.Per the customer, they no longer have questions about the false positive and consider this issue resolved.A review of the instrument's log file showed conditions as normal - no instrument issues noted.The root cause cannot be determined.There was no malfunction of the instrument reported and as such this is an unconfirmed complaint.Some of this information was recorded in the related case (b)(4).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 the related case has been closed - (b)(4).No samples or parts were expected to be returned for this complaint and thus, a returned sample analysis is not required.Bd quality will continue to closely monitor for trends associated with instrument performance/operation 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 bd bactec¿ mgit¿ 320 instrument, there was a false positive result.There was no report of adverse impact to patient.

• Brand Name: BD BACTEC¿ MGIT¿ 320 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23990300
• Report Number: 1119779-2026-00003
• Device Sequence Number: 10185005
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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