MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SYSTEM; SYSTEM, BLOOD CULTURING

Catalog Number 445870

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

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.

Event Description

It was reported that when using the bd bactec¿ mgit¿ 960 system, five false positives occurred.No patient impact or injury reported.

Manufacturer Narrative

H.6 investigation summary: a complaint of "customer reports fps from the b drawer" was received against bactec mgit 960 instrument material number: 445870, serial number: (b)(6).A bd remote assistance associate communicated with the customer and verified the log files and observed that there were no instrument related issues.Instrument was found to be functional, and the customer started using the instrument for regular operation.This is an unconfirmed complaint, and the root cause was unable to be determined.Device history record review for the instrument (b)(6), is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review revealed no previous complaints for this issue.Samples were reviewed in the form of log files and no instrument related issues were observed.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.

Event Description

It was reported that when using the bd bactec¿ mgit¿ 960 system, five false positives occurred.No patient impact or injury reported.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SYSTEM
• Type of Device: 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: 18969923
• MDR Text Key: 338590626
• Report Number: 1119779-2024-00222
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: (01)00382904458706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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
• Device Operator: Other
• Device Catalogue Number: 445870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1