MalfunctionQBX

T2BACTERIA PANEL

Received Oct 24, 2024 · Event occurred Sep 21, 2024

Report 3010097867-2024-00030 · MDR key 20522417

Device

Generic name

Direct Blood Bacterial Nucleic Acid Detection System

Manufacturer

T2 Biosystems, Inc.

Model number

T2BACTERIA PANEL

Catalog number

80-08072

Lot number

WO-62051

Product problems

False Negative Result
False Negative Result

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 26 SEPTEMBER 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A SUSPECTED CLINICAL FALSE NEGATIVE P. AERUGINOSA RESULT USING THE T2BACTERIA PANEL..