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 Insufficient Information (4580)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

T2 biosystems' distributor (italy) relayed a customer complaint that the t2bacteria panel resulted in two positive pseudomonas aeruginosa results on negative clinical samples after being run on t2dx instrument isa3317000134.After multiple inquiries by t2 biosystems, the customer refused to provide details associated with the reference assay that classified the false positive outcomes, patient details, or any impact to treatment.This is the first of two discrepant results.Specific run data was transferred to t2 biosystems for review/evaluation and a field service engineer (fse) was dispatched to the clinic on 20 july 2022; the t2bacteria panel and associated blood samples were discarded after use.The collective findings suggested an instrument failure (miscalibration) of the two instrument drawers where the false positive results were obtained, as well as non-optimal pump performance.The fse recalibrated and decontaminated the t2dx instrument during the 20 july 2022 visit.T2bacteria controls were run successfully and the system was released back to the customer.

• 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: 15168201
• MDR Text Key: 302494233
• Report Number: 3010097867-2022-00028
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/04/2022

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: 12/17/2022
• Device Model Number: T2BACTERIA PANEL
• Device Catalogue Number: 80-07342
• Device Lot Number: 20330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/04/2022
• 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