Brand Name | COBAS INFINITY LAB CORE LICENSE 3.X |
Type of Device | CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
ROCHE INSTRUMENT CENTER AG TEGIMENTA |
forrenstrasse |
na |
rotkreuz 6343 |
SZ
6343
|
|
Manufacturer Contact |
amy
nelson
|
9115 hague road |
na |
indianapolis, IN 46250
|
3174767531
|
|
MDR Report Key | 16548129 |
MDR Text Key | 311370267 |
Report Number | 1823260-2023-00815 |
Device Sequence Number | 1 |
Product Code |
JQP
|
UDI-Device Identifier | 07613336177129 |
UDI-Public | 07613336177129 |
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/25/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/13/2023
|
Initial Date FDA Received | 03/15/2023 |
Supplement Dates Manufacturer Received | 04/21/2023 04/20/2023
|
Supplement Dates FDA Received | 05/15/2023 05/25/2023
|
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
|
Removal/Correction Number | RES 92085 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|