FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2080291
·
Received March 30, 2011
Report
- Report Number
- 2027969-2011-00647
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- February 14, 2011
- Report Date
- March 30, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
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: 1.5, LAB: 4.1. DATE: (B)(6) 2011, 3.7, 4.1. PT'S THERAPEUTIC RANGE IS 2-3. IN THE BEGINNING OF FEB, PT WAS GIVEN BENADRYL AND ANTIBIOTICS DUE TO A RASH. HE WAS ON ANTIBIOTICS FOR ABOUT 6 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |