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

Catalog Number 445870

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that while using the bd bactec¿ mgit¿ 960 system that there was false resistance to pyrazinamide antibiotic.No patient impact reported.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Report 1 of 5: it was reported that while using the bd bactec¿ mgit¿ 960 system that there was false resistance to pyrazinamide antibiotic.No patient impact reported.

Manufacturer Narrative

A.3.Sex: male.B.3.Date of event: 01-mar-2024.B.5.Describe event: report 1 of 5: it was reported that while using the bd bactec¿ mgit¿ 960 system that there was false resistance to pyrazinamide antibiotic.No patient impact reported.Investigation summary: catalog # 445870, s/n (b)(6): the customer reported as having issues with resistance testing with false resistance being reported.No patient impact was reported.Through remote assistance and based on the customer's workflow, the customer was provided instructions on how to confirm and monitor their process.It was reported that this may take some time to complete.From the information provided, the root cause could not be determined, and the problem code entered into service max was listed as unable to replicate issue.This complaint is not being confirmed as no instrument malfunction was identified.Review of the device history record for instrument s/n mg6036 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.If additional information is received at a later date, the complaint may be reopened for further investigation.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¿ 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: 19125119
• MDR Text Key: 341167048
• Report Number: 1119779-2024-00296
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: (01)00382904458706
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

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: 03/19/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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
• Patient Sex: Male