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

Catalog Number	441743
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec¿ mgit¿ 320 system that there were false positives for mbt as a result of possible contamination.No patient impact.The following information was provided by the initial reporter: "customer reports that they have detected several incidents with vials turning positive in less than 48hrs incubation and flagging positive with a gu=0.Customer report some of the vials give a positive for other bacterial growth but no for mtb.".
Additional Manufacturer Narrative
H.3.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
Catalog # 441743, s/n (b)(6): the customer initially reported vials flagging positive with gu=0.The customer was contacted and reported that they were unsure if the samples were false positives and could not provide any more information.This case is being closed.Based on the customer's information and that no instrument malfunction was reported this complaint is not confirmed.A root cause could not be determined.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 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 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 that while using bd bactec¿ mgit¿ 320 system that there were false positives for mbt as a result of possible contamination.No patient impact.The following information was provided by the initial reporter: "customer reports that they have detected several incidents with vials turning positive in less than 48hrs incubation and flagging positive with a gu=0.Customer report some of the vials give a positive for other bacterial growth but no for mtb.

• Brand Name: BD BACTEC¿ MGIT¿ 320 SYSTEM
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17968353
• Report Number: 1119779-2023-01156
• Device Sequence Number: 6565415
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: 00382904417437
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/23/2023

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: 09/29/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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