FDA Adverse Event
Injury
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 4060296
·
Received August 25, 2014
Report
- Report Number
- 2027969-2014-00777
- Event Type
- Injury
- Date Received
- August 25, 2014
- Date of Event
- August 3, 2014
- Report Date
- August 4, 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
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LAB INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 2.4, LAB INR: 12.5. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS AT LEAST TWO (2) HOURS. REPORTEDLY, THE PT WAS EXPERIENCING SIGNIFICANT BRUISING ON LEGS AND BLEEDING FROM THE MOUTH ON (B)(6) 2014. PT WAS SEEN IN THE EMERGENCY ROOM WHERE THE LAB INR WAS 12.5. THE PT WAS HOSPITALIZED WITH HIGH INR, EXCESSIVE BRUISING AND BLEEDING. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513572 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 344683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | INRATIO MONITOR: SN (B)(4)| WARFARIN 3MG DAILY |