FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1922877
·
Received December 6, 2010
Report
- Report Number
- 2027969-2010-02121
- Event Type
- Other
- Date Received
- December 6, 2010
- Date of Event
- November 8, 2010
- Report Date
- December 6, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" LAST WEEK (DATE UNK): 3.2, THEN 1.1 ON SAME FINGER. TODAY: 2.2, THEN 1.3 ON NEW FINGER, THEN 1.6 ON SAME FINGER. CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0, AND HER INR IS USUALLY VERY STABLE IN THAT RANGE. GOT NEW LOT OF STRIPS AND HER INR WAS FLUCTUATING MORE, SO HER DOCTOR CHANGED HER DOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |