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

Model Number T2BACTERIA PANEL

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

T2 biosystems' distributor (italy) relayed a customer complaint that the t2bacteria panel resulted in a positive staphylococcus aureus result on a negative clinical sample after being run on t2dx instrument isa3317000134.The customer reported the false positive result as compared to negative blood culture of the same venous collection.Patient details were not provided.Based on the information provided by the distributor, there was no allegation from the institution that the alleged false positive led to an adverse event or patient harm.Specific run data was transferred to t2 biosystems for review and evaluation and a field service engineer (fse) was dispatched to the clinic on (b)(6) 2022; the t2bacteria panel and associated blood samples were discarded after use.Review of the design history records of the associated t2bacteria lot (wo-20570) resulted in no findings related to product quality.Fse observation of the customer's sample preparation methods suggested procedures that deviated from the ifu.T2 biosystems fse advised on best practices for sample handling and instrument maintenance according to the ifu and operator manual.

• 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: 15512060
• MDR Text Key: 306412719
• Report Number: 3010097867-2022-00031
• Device Sequence Number: 1
• Product Code: QBX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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