Brand Name | COAGUCHEK XS |
Type of Device | TEST, TIME, PROTHROMBIN |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS GMBH |
9115 hague rd |
indianapolis IN 46250 |
|
MDR Report Key | 8074994 |
MDR Text Key | 127395750 |
Report Number | MW5081333 |
Device Sequence Number | 1 |
Product Code |
GJS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
11/13/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/14/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Expiration Date | 10/31/2019 |
Device Lot Number | 31404821 |
Was Device Available for Evaluation? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Disability;
|
Patient Age | 53 YR |
|
|