FDA Adverse Event
Injury
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 3940593
·
Received June 18, 2014
Report
- Report Number
- 2027969-2014-00590
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 28, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO INR RESULT IN COMPARISON THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 3.0. THE TIME BETWEEN TESTING WAS FIVE (5) MINUTES BETWEEN THE INRATIO TESTING AND APPROXIMATELY TWO (2) HOURS BETWEEN THE SECOND INRATIO TEST AND THE LABORATORY TEST. THE PATIENT'S WARFARIN WAS INCREASED FROM 5MG TO 8 MG DAILY BASED ON THE LABORATORY INR RESULT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358196 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 341995 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INRATIO MONITOR SN UNKNOWN, WARFARIN 5MG DAILY |