MAUDE Adverse Event Report: T2 BIOSYSTEMS, INC T2BACTERIA PANEL; DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM

Model Number T2BACTERIA PANEL

Device Problem False Negative Result (1225)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

Incident occured at evaluation site, therefore no patient treatment decisions were based on the results of the t2 test.

Event Description

(b)(6) 2023: t2 bioystems received a customer complaint that the t2bacteria panel produced a discordant result.The t2bacteria panel produced a "target not detected" result compared to a positive blood culture result for e.Coli.

• Brand Name: T2BACTERIA PANEL
• Type of Device: DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM
• Manufacturer (Section D): T2 BIOSYSTEMS, INC; 101 hartwell avenue; lexington MA 02421
• Manufacturer (Section G): T2 BIOSYSTEMS, INC; 101 hartwell avenue; lexington MA 02421
• Manufacturer Contact: scott blood ; 101 hartwell avenue; lexington, MA 02421 ; 7814571206
• MDR Report Key: 18588688
• MDR Text Key: 334841372
• Report Number: 3010097867-2024-00001
• Device Sequence Number: 1
• Product Code: QBX
• UDI-Device Identifier: M70880073423
• UDI-Public: +M70880073423/$$3241106WO22965J
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-07342
• Device Lot Number: WO-22965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1