Brand Name | INRATIO PT/INR TEST STRIPS |
Type of Device | PROTHROMBIN TIME TEST |
Manufacturer (Section D) |
ALERE SAN DIEGO, INC. |
9975 summers ridge road |
san diego CA 92121 |
|
Manufacturer (Section G) |
ALERE SAN DIEGO, INC. |
9975 summers ridge road |
|
san diego CA 92121 |
|
Manufacturer Contact |
ya-ling
king
|
9975 summers ridge road |
san diego, CA 92121
|
8588052084
|
|
MDR Report Key | 4601754 |
MDR Text Key | 5701578 |
Report Number | 2027969-2015-00185 |
Device Sequence Number | 1 |
Product Code |
GJS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K092987 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
02/23/2015 |
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 |
Lay User/Patient
|
Device Model Number | 100071 |
Device Lot Number | 357499 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/23/2015
|
Initial Date FDA Received | 03/13/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | UNSPECIFIED THYROID MEDICATION; MD'S INRATIO PT/INR TEST STRIPS 100139, LOT 345309; PHYSICIAN'S INRATIO MONITOR SN (B)(4); WARFARIN 4M DAILY; MD'S INRATIO PT/INR TEST STRIPS 100139, LOT 345309; PATIENT'S INRATIO MONITOR SN (B)(4); PATIENT'S INRATIO MONITOR SN (B)(4); PHYSICIAN'S INRATIO MONITOR SN (B)(4) |