MalfunctionQBX
T2BACTERIA PANEL
Received Aug 13, 2024 · Event occurred Jul 17, 2024
Report 3010097867-2024-00026 · MDR key 19971213
Device
Generic name
Direct Blood Bacterial Nucleic Acid Detection System
Manufacturer
T2 Biosystems, IncModel number
T2BACTERIA PANELCatalog number
80-07342
Lot number
WO-23694
Product problems
- False Positive Result
- False Positive Result
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
18 JULY 2024: T2BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE P. AERUGINOSA RESULT USING THE T2BACTERIA PANEL