FDA Adverse Event
Malfunction
Summary report: N
T2BACTERIA PANEL
MDR report key: 19927401
·
Received August 7, 2024
Report
- Report Number
- 3010097867-2024-00025
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- June 25, 2024
- Report Date
- August 7, 2024
- Manufacturer
- T2 BIOSYSTEMS, INC
- Product Code
- QBX
- UDI-DI
- M70880073423
- PMA / PMN Number
- K233184
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
8 JULY 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2BACTERIA PANEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561277 | T2BACTERIA PANEL | DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM | QBX | T2 BIOSYSTEMS, INC | T2BACTERIA PANEL | WO-23782 | M70880073423 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |