FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1946236
·
Received December 28, 2010
Report
- Report Number
- 2027969-2010-02291
- Event Type
- Other
- Date Received
- December 28, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 28, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2010, INRATIO: 7.3, DATE: (B)(6) 2010, INRATIO: 5.2. COUMADIN DOSE WITH HELD AFTER 7.3 RESULT ON (B)(6) 2010. PT NOTICED BRUISING THE NIGHT OF (B)(6) 2010. TARGET THERAPEUTIC RANGE IS 2.5 TO 3.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |