FDA Adverse Event
Summary report: N
INRATIO2
MDR report key: 2010413
·
Received February 23, 2011
Report
- Report Number
- 2027969-2011-00387
- Date Received
- February 23, 2011
- Date of Event
- January 27, 2011
- Report Date
- February 23, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.3, LAB: 2.8, THERAPEUTIC RANGE: 2.0-2.9. PT CONFIRMED NO CHANGE IN DIET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 243103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |