MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD MGIT 960 PZA; SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Catalog Number 245128

Patient Problem Insufficient Information (4580)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

Multiple qc failures associated with bd mgit 960 pza (pyrazinamide) caused the laboratory to be unable to report susceptibility results for this critical drug used to treat patients with mycobacterium tuberculosis infections.This is an issue that has impacted multiple other public health labs throughout the country.Lots: 2160598; 3191569; 3241654.

• Brand Name: BD MGIT 960 PZA
• Type of Device: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO.
• MDR Report Key: 18640727
• MDR Text Key: 334649995
• Report Number: MW5151028
• Device Sequence Number: 1
• Product Code: MJA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/31/2024

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: Health Professional
• Device Catalogue Number: 245128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male