FDA Adverse Event
Other
Summary report: N
INRATIO2
MDR report key: 1791920
·
Received August 4, 2010
Report
- Report Number
- 2027969-2010-01131
- Event Type
- Other
- Date Received
- August 4, 2010
- Date of Event
- July 15, 2010
- Report Date
- August 4, 2010
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PATIENT SELF TESTER HAD DISCREPANT RESULTS. PATIENT GIVEN LOVENOX AFTER HER 1.1 RESULT. PATIENT IS NO LONGER RECEIVING LOVENOX. NEW LOT (#222168) USED ON (B)(6) 2010. PATIENT'S TARGET THERAPEUTIC RANGE IS 3.0-4.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | BIOSITE INCORPORATED | 100139 | 232886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |