FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2213875
·
Received August 5, 2011
Report
- Report Number
- 2027969-2011-01751
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 8, 2011
- Report Date
- August 5, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWED:" DATE: (B)(6) 2011, INRATIO: 6.4, LAB: 4.0. THE PT TOOK THEIR LAST DOSE OF COUMADIN ON (B)(6). THE TIME BETWEEN TESTING WAS TWO HOURS AND THE PT'S THERAPEUTIC RANGE IS BETWEEN 2.0 AND 3.0. THE PT IS TAKING FLONASE AND HYDROCORTISONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 253025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |