Brand Name | ELECSYS T4 ASSAY |
Type of Device | RADIOIMMUNOASSAY, TOTAL THYROXINE |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
MDR Report Key | 7965362 |
MDR Text Key | 123868412 |
Report Number | 1823260-2018-03669 |
Device Sequence Number | 1 |
Product Code |
CDX
|
UDI-Device Identifier | 04015630912728 |
UDI-Public | 04015630912728 |
Combination Product (y/n) | N |
PMA/PMN Number | K961490 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
01/07/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/15/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | ASKU |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/26/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 62 YR |
|
|