MalfunctionQBX

T2BACTERIA PANEL

Received Sep 11, 2024 · Event occurred Aug 11, 2024

Report 3010097867-2024-00027 · MDR key 20188928

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

Additional Manufacturer Narrative

AFTER REVIEW OF THE DATA, THERE DO NOT APPEAR TO BE ANY ISSUES ATTRIBUTABLE TO CONTAMINATION OR HANDLING.

Description of Event or Problem

(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A POSITIVE P. AERUGINOSA RESULT COMPARED TO POSITIVE BLOOD CULTURE AND URINE CULTURE RESULTS FOR S. AUREUS.