FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2070788
·
Received April 15, 2011
Report
- Report Number
- 2027969-2011-00843
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- March 21, 2011
- Report Date
- April 15, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, 7:00PM INRATIO= 2.8, 12:00PM LAB= 5.03. DATE: (B)(6) 2011, INRATIO= 4.0. PT SELF TESTER DID NOT NOTICE ANY BRUISING/BLEEDING. PT STARTED COUMADIN AND AMIODARONE ABOUT 4 WEEKS AGO WHEN SHE WAS ADMITTED TO THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 246050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |