Brand Name | T2BACTERIA PANEL |
Type of Device | DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM |
Manufacturer (Section D) |
T2 BIOSYSTEMS, INC |
101 hartwell avenue |
lexington MA 02421 |
|
Manufacturer (Section G) |
T2 BIOSYSTEMS, INC |
101 hartwell avenue |
|
lexington MA 02421 |
|
Manufacturer Contact |
scott
blood
|
101 hartwell avenue |
lexington, MA 02421
|
7814571206
|
|
MDR Report Key | 18880588 |
MDR Text Key | 337800580 |
Report Number | 3010097867-2024-00003 |
Device Sequence Number | 1 |
Product Code |
QBX
|
UDI-Device Identifier | M70880080723 |
UDI-Public | +M70880080723/$$3240821WO22797Q |
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | K233184 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/11/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | T2BACTERIA PANEL |
Device Catalogue Number | 80-08072 |
Device Lot Number | WO-22797 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/13/2024
|
Initial Date FDA Received | 03/11/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/10/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 70 YR |
Patient Sex | Male |
|
|