FDA Adverse Event
Injury
Summary report: N
INRATIO2
MDR report key: 1773670
·
Received July 22, 2010
Report
- Report Number
- 2027969-2010-01023
- Event Type
- Injury
- Date Received
- July 22, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 22, 2010
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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: SEE SCANNED TABLE. PT STARTED USING THE INRATIO2 METER THREE WEEKS AGO. SHE WAS TOLD BY HER DOCTOR TO HOLD HER COUMADIN DOSE ON (B)(6)2010, AND THEN ALSO ON (B)(6)2010 FOR SEVERAL DAYS. PT HAS NO BRUISING OR BLEEDING. THE FOLLOWING INRATIO RESULT WAS OBTAINED USING A NEW STRIP LOT# 234130: DATE: (B)(6)2010, INRATIO: 6.8.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | BIOSITE INCORPORATED | 100071 | 232167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |