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	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bactec mgit 320 instrument, an unspecified number of false positives was received.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
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
Investigation summary catalog #441743, s/n (b)(6): the customer states that there were false negatives reported by the instrument.Through remote assistance, customer communication and recommended testing it was determined that it was possible that the samples did not have enough growth to test positive or that there was an error when seeding the samples.The service max case, (b)(4), was closed.The root cause 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 recent additional work orders were observed for the complaint failure mode reported.A related case, (b)(4), case (b)(4), was recorded but cancelled because it was a duplicate of this case.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, an unspecified number of false positives was received.No adverse impact was reported regarding the patient or user.

• 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: 20925894
• Report Number: 1119779-2024-00994
• Device Sequence Number: 14775894
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437(11)221115
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 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: 11/27/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2022
• 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