MalfunctionQBX
T2BACTERIA PANEL
Received Aug 7, 2024 · Event occurred Jun 16, 2024
Report 3010097867-2024-00023 · MDR key 19927318
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 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
(B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL