Brand Name | COAGUCHEK ® XS SYSTEM |
Type of Device | PROTHROMBIN TIME TEST STRIPS |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 |
|
Manufacturer (Section G) |
ROCHE DIAGNOSTICS GMBH |
sandhoferstrasse 116 |
na |
mannheim (baden-wurttemberg) 6830 5 |
GM
68305
|
|
Manufacturer Contact |
michael
leslie
|
9115 hague road |
na |
indianapolis, IN 46250
|
3175214343
|
|
MDR Report Key | 4787966 |
MDR Text Key | 5856708 |
Report Number | 1823260-2015-03503 |
Device Sequence Number | 1 |
Product Code |
GJS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K062925 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/11/2015 |
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 |
Unknown
|
Device Expiration Date | 01/31/2016 |
Device Catalogue Number | 04625315160 |
Device Lot Number | 22929812 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/05/2015 |
Is the Reporter a Health Professional? |
No
|
Event Location |
Ambulatory Health Care Facility
|
Initial Date Manufacturer Received |
04/29/2015
|
Initial Date FDA Received | 05/21/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/11/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/14/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | COUMADIN; UNKNOWN CHOLESTEROL PILL; UNKNOWN BLOOD PRESSURE PILL |
Patient Age | 060 YR |
Patient Weight | 104 |