Brand Name | VITEK® 2 GN TEST KIT |
Type of Device | VITEK® 2 GN TEST KIT |
Manufacturer (Section D) |
BIOMERIEUX, INC |
595 anglum road |
saint louis MO 63042 |
|
Manufacturer (Section G) |
BIOMERIEUX, INC |
595 anglum road |
|
saint louis MO 63042 |
|
Manufacturer Contact |
ellen
weltmer
|
595 anglum road |
saint louis, MO 63042
|
|
MDR Report Key | 6388983 |
MDR Text Key | 69560543 |
Report Number | 1950204-2017-00084 |
Device Sequence Number | 1 |
Product Code |
JTO
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K910666 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/09/2017 |
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 Expiration Date | 08/13/2017 |
Device Model Number | 21341 |
Device Lot Number | 241389540 |
Other Device ID Number | 03573026131913 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/08/2017 |
Initial Date FDA Received | 03/08/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/09/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|