FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1934161
·
Received December 14, 2010
Report
- Report Number
- 2027969-2010-02173
- Event Type
- Other
- Date Received
- December 14, 2010
- Date of Event
- November 24, 2010
- Report Date
- December 14, 2010
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" (B)(6) 2010: INR = 1.3 (COUMADIN DOSE INCREASED); (B)(6) 2010: INR = 2.1; (B)(6) 2010: INR = 2.7. THERAPEUTIC RANGE = 2-3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 100410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |