FDA Adverse Event
Other
Summary report: N
INRATIO2
MDR report key: 1943031
·
Received December 23, 2010
Report
- Report Number
- 2027969-2010-02265
- Event Type
- Other
- Date Received
- December 23, 2010
- Date of Event
- December 3, 2010
- Report Date
- December 23, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER WAS GETTING 4NN ERRORS AND UNEXPECTED LOW RESULTS. AFTER GETTING THE 4NN ERRORS, HE GOT A 1.5 INR HE NOTED THAT HIS RESULTS SINCE STARTING ON THE METER (JUST A FEW WEEKS AGO) HAVE BEEN MUCH LOWER THAN USUAL. HIS THERAPEUTIC RANGE IS 2.0-3.0, AND HE HAS BEEN AT 1.4-1.5 LATELY. HIS DOCTOR RAISED HIS COUMADIN DOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 235737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |