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 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

T2 biosystems' received a customer complaint that the t2bacteria panel produced a negative e.Coli result on a reported positive clinical sample using t2dx instrument (b)(4).The customer reported the false negative result as compared to positive blood and urine cultures.The t2bacteria specimen was collected at the same time as the first set of blood cultures.No additional patient information was provided.A t2 service engineer was dispatched to the clinical site.Instrument logs and run data were reviewed.There were no findings that an instrument-related failure occurred.Qa review of t2bacteria lot wo-20579 was performed and no abnormalities related to the manufacture and testing of this lot were identified.The customer was referred to the t2bacteria instructions for use section, "limitations of the procedure", that states: a negative panel result does not exclude the possibility of bloodstream infection.Negative panel results may occur from sequence variants in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up, or an infection caused by an organism not detected in the panel.Panel results may also be affected by levels of organism in the sample that are below the limit of detection of the test.Negative results should not be used as the sole basis for diagnosis, treatment, or other management decisions.

Event Description

On (b)(6) 2022, a t2 customer logged a 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: 15819983
• MDR Text Key: 307808127
• Report Number: 3010097867-2022-00035
• Device Sequence Number: 1
• Product Code: QBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

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: 03/17/2023
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-07342
• Device Lot Number: WO-20579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/17/2022
• 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