FDA Adverse Event
Injury
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 4101632
·
Received August 27, 2014
Report
- Report Number
- 2027969-2014-00791
- Event Type
- Injury
- Date Received
- August 27, 2014
- Date of Event
- August 6, 2014
- Report Date
- August 6, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO AN ALTERNATE POINT OF CARE (POC) INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR: 5.3 AND 5.1 (5 MINUTES APART), POC INR: 1.6 AND 1.5 (5 MINUTES APART). THERAPEUTIC RANGE: 2.0-3.0. THE PATIENT HELD HIS WARFARIN ON (B)(6) 2014 AS A RESULT OF THE INRATIO RESULTS. NO FURTHER TESTING (INRATIO OR LABORATORY) WAS PERFORMED UNTIL (B)(6) 2014 AT WHICH TIME A NEW INRATIO STRIP LOT SHOWED INR OF 3.1. THE PATIENT WAS SATISFIED WITH THE RESULT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522815 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 332829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | INRATIO MONITOR SN: (B)(4)| WARFARIN 7.5MG |