Brand Name | VITEK® 2 AST-P654 TEST KIT |
Type of Device | AST-P654 TEST KIT 20 CARDS - 421912 |
Manufacturer (Section D) |
BIOMERIEUX, INC. |
595 anglum road |
hazelwood MO 63042 |
|
Manufacturer (Section G) |
BIOMERIEUX, INC. |
595 anglum road |
|
595 anglum road MO 63042 |
|
Manufacturer Contact |
jennifer
armstrong
|
595 anglum road |
hazelwood, MO 63042
|
3145068201
|
|
MDR Report Key | 9525266 |
MDR Text Key | 219778692 |
Report Number | 1950204-2019-00330 |
Device Sequence Number | 1 |
Product Code |
LON
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K053097 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/27/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/02/2021 |
Device Catalogue Number | 421912 |
Device Lot Number | 8041164103 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/11/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/04/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |