MalfunctionQBX
T2BACTERIA PANEL
Received Oct 18, 2024 · Event occurred Sep 16, 2024
Report 3010097867-2024-00029 · MDR key 20486485
Device
Generic name
Direct Blood Bacterial Nucleic Acid Detection System
Manufacturer
T2 Biosystems, Inc.Model number
T2BACTERIA PANELCatalog 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
(B)(6) 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A SUSPECTED CLINICAL FALSE NEGATIVE E. COLI RESULT USING THE T2BACTERIA PANEL.