MalfunctionQBX
T2BACTERIA PANEL
Received Sep 17, 2024 · Event occurred Aug 13, 2024
Report 3010097867-2024-00028 · MDR key 20239756
Device
Generic name
Direct Blood Bacterial Nucleic Acid Detection System
Manufacturer
T2 Biosystems, Inc.Product problems
- False Positive 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
19 AUGUST 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE S. AUREUS RESULT USING THE T2BACTERIA PANEL.