FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1893871
·
Received November 1, 2010
Report
- Report Number
- 2027969-2010-01840
- Event Type
- Malfunction
- Date Received
- November 1, 2010
- Date of Event
- October 11, 2010
- Report Date
- November 1, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PATIENT SELF TESTER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: UNK, INRATIO: 3.6. DATE: UNK, LAB: 1.8. TIME BETWEEN RESULTS WAS APPROX 1 WEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |