MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC MGIT 320 INSTRUMENT; SYSTEM, BLOOD CULTURING

Catalog Number	441743
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec mgit 320 instrument, two (2) tubes resulted as false negative.The tubes were removed from the instrument for gram stain and subculture and no growth was detected.After re-incubation and subsequent gram stain and subculture, growth was detected.No patient results were affected as the final results were reported as positive.
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.
Event or Problem Description
It was reported that while using bd bactec mgit 320 instrument, two (2) tubes resulted as false negative.The tubes were removed from the instrument for gram stain and subculture and no growth was detected.After re-incubation and subsequent gram stain and subculture, growth was detected.No patient results were affected as the final results were reported as positive.
Additional Manufacturer Narrative
Investigation summary: catalog # 441743, s/n (b)(6): the customer reported false negative results for sample tubes.Through remote assistance it was requested for the customer to provide a report on the workflow concerning the tubes.The instrument was not showing any alert or error messages.A case was opened under reagents and samples are being returned under that case (b)(4)/(b)(4).The root cause for this complaint pr (b)(4) could not be not determined.This complaint is not being confirmed as no instrument malfunction was identified.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.No samples or parts from the instrument were expected to be returned for this complaint and thus, a returned sample analysis is not required (note: reagent complaint samples are scheduled to be returned).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.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20390966
• Report Number: 1119779-2024-00736
• Device Sequence Number: 12779069
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437(11)150924
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2015
• 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