FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2935144
·
Received January 14, 2013
Report
- Report Number
- 2027969-2013-00038
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 28, 2012
- Report Date
- January 14, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO RESULTS IN COMPARISON TO THE LAB RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 1.7, LABORATORY INR: 4.8. THE TIME BETWEEN TESTING WAS 1 HOUR. THERAPEUTIC RANGE WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21304 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 297457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COUMADIN 4MG DAILY |