Brand Name | TOTAL PSA ELECSYS E2G 300 V2 |
Type of Device | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
ROCHE DIAGNOSTICS GMBH |
sandhoferstrasse 116 |
na |
mannheim (baden-wurttemberg) 68305 |
GM
68305
|
|
Manufacturer Contact |
michael
leslie
|
9115 hague road |
na |
indianapolis, IN 46250
|
3175214343
|
|
MDR Report Key | 12666991 |
MDR Text Key | 277712051 |
Report Number | 1823260-2021-03072 |
Device Sequence Number | 1 |
Product Code |
LTJ
|
UDI-Device Identifier | 07613336165980 |
UDI-Public | 07613336165980 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P990056 |
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 |
Report Date |
10/20/2021 |
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 | 11/30/2021 |
Device Catalogue Number | 08791732190 |
Device Lot Number | 49236103 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/29/2021
|
Initial Date FDA Received | 10/20/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |