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

Model Number	T2BACTERIA PANEL
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After review of the data, there do not appear to be any issues attributable to contamination or handling.
Event or Problem Description
(b)(6) 2024: t2 bioystems received a customer complaint that the t2bacteria panel produced a discordant result.The t2bacteria panel produced a positive p.Aeruginosa result compared to positive blood culture and urine culture results for s.Aureus.

• 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: 20188928
• Report Number: 3010097867-2024-00027
• Device Sequence Number: 8069984
• Product Code: QBX
• UDI-Device Identifier: M70880073423
• UDI-Public: +M70880073423/$$3250515WO23694N
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 05/15/2025
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-07342
• Device Lot Number: WO-23694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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