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	10/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Instrument had multiple hardware failures leading to errors and invalid results.T2 service engineer has replaced faulty hardware and is in the process of testing the instrument.
Event or Problem Description
7 november 2024: t2biosystems received a customer complaint of a suspected clinical false negative e.Coli result using the t2bacteria panel.

• 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): T2BIOSYSTEMS, INC.; 101 hartwell avenue; lexington MA 02421
• Manufacturer Contact: scott blood ; 101 hartwell avenue; lexington, MA 02421 ; 7814571206
• MDR Report Key: 20867792
• Report Number: 3010097867-2024-00031
• Device Sequence Number: 8591913
• Product Code: QBX
• UDI-Device Identifier: M70880080723
• UDI-Public: +M70880080723/$$3250908WO3618O
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 09/08/2025
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-08072
• Device Lot Number: WO-36108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2024
• 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 Sex: Unknown