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

Model Number	T2BACTERIA PANEL
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 3010097867-2024-00003
• Device Sequence Number: 9255536
• Product Code: QBX
• UDI-Device Identifier: M70880080723
• UDI-Public: +M70880080723/$$3240821WO22797Q
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K233184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2024
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-08072
• Device Lot Number: WO-22797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male