FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2935175
·
Received January 14, 2013
Report
- Report Number
- 2027969-2013-00034
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 25, 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
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO 2 RESULTS IN COMPARISON TO THE LAB RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 2.9, LAB INR: 1.6. THE TIME BETWEEN TESTING WAS 2 HOURS. THERAPEUTIC RANGE 2.5-3.0 FOR PT. 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 |
|---|---|---|---|---|---|---|---|
| 21306 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 297457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AUGMENTIN| COUMADIN 3MG/DAY| LOVENOX |