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 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

T2 biosystems' distributor (turkey) relayed a customer complaint that the t2bacteria panel produced a negative e.Coli result on a reported positive clinical sample using t2dx instrument isa1821000281.The customer reported the false negative result as compared to positive blood culture.The reporter also made a statement suspecting contamination of the blood culture used in comparison, that has not been confirmed.After multiple inquiries by t2, details related to patient demographics and patient treatment were not provided by the customer.Specific run data was also not transferred preventing any further investigation by t2 service engineers.Quality checks were run by the customer and confirmed functionality and performance of the t2dx instrument.

Event Description

On (b)(6) 2022, a t2 distributor relayed a customer complaint of a clinical false negative result using the t2bacteria panel.

• 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: bill jacques ; 101 hartwell avenue; lexington, MA 02421 ; 7817614635
• MDR Report Key: 15597184
• MDR Text Key: 306811707
• Report Number: 3010097867-2022-00033
• Device Sequence Number: 1
• Product Code: QBX
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K172708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-08072
• Device Lot Number: WO-20570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1