FDA Adverse Event
Injury
Summary report: N
INRATIO2
MDR report key: 2422809
·
Received January 11, 2012
Report
- Report Number
- 2027969-2012-00035
- Event Type
- Injury
- Date Received
- January 11, 2012
- Date of Event
- December 23, 2011
- Report Date
- January 10, 2012
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- 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
CUSTOMER ALLEGES DISCREPANT RESULTS FROM ONE PT WITH THE METER COMPARED TO THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO INR: 1.4, LAB INR: 3.4. COMPARED A FEW MINUTES APART. CUSTOMER STATED THAT THE PT'S MEDICATION WAS CHANGED BASED OFF INRATIO RESULT: LAB WORK WAS DONE AND FOUND TO BE GREATLY DIFFERENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |