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 02/05/2024

Event Type  malfunction  

Event Description

(b)(6) 2024: t2 bioystems received a customer complaint that the t2bacteria panel produced a negative result compared to a positive blood culture result for pseudomonas aeruginosa.

• 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: 18880588
• MDR Text Key: 337800580
• Report Number: 3010097867-2024-00003
• Device Sequence Number: 1
• Product Code: QBX
• UDI-Device Identifier: M70880080723
• UDI-Public: +M70880080723/$$3240821WO22797Q
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K233184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 80-08072
• Device Lot Number: WO-22797
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male