FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1812713
·
Received August 16, 2010
Report
- Report Number
- 2027969-2010-01212
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Date of Event
- July 26, 2010
- Report Date
- August 16, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
DISCREPANT RESULTS REPORTED: (B)(6) 2010, INRATIO: 1.6, LAB: 2.4 (APPROX 2-5 HOURS BETWEEN RESULTS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 232232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |