MalfunctionQBX

T2BACTERIA PANEL

Received Aug 7, 2024 · Event occurred Jun 14, 2024

Report 3010097867-2024-00022 · MDR key 19927287

Device

Generic name

Direct Blood Bacterial Nucleic Acid Detection System

Manufacturer

T2 Biosystems, Inc

Model number

T2BACTERIA PANEL

Catalog number

80-07342

Lot number

WO-23694

Product problems

False Negative Result
False Positive Result
False Negative Result
False Positive Result

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A POSITIVE K. PNEUMONIAE RESULT COMPARED TO A POSITIVE BLOOD CULTURE RESULT FOR E. COLI.