Brand Name | ASSAYTIP/ASSAYCUP TRAY |
Type of Device | EQUIPMENT, LABORATORY, GENERAL PURPOSE |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
MDR Report Key | 8150361 |
MDR Text Key | 130639771 |
Report Number | 1823260-2018-04756 |
Device Sequence Number | 1 |
Product Code |
LXG
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup,Followup |
Report Date |
12/16/2019 |
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 | E801 |
Device Catalogue Number | 05694302001 |
Device Lot Number | 18668170 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/13/2018 |
Initial Date FDA Received | 12/11/2018 |
Supplement Dates Manufacturer Received | 11/13/2018 11/13/2018
|
Supplement Dates FDA Received | 01/07/2019 12/16/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | RES 83646 |
Patient Sequence Number | 1 |
|
|