FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2891402
·
Received December 26, 2012
Report
- Report Number
- 2027969-2012-01738
- Event Type
- Malfunction
- Date Received
- December 26, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 24, 2012
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, INRATIO2: 1.5, 1.2, LAB: 8.9. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS THREE HRS. PT'S THERAPEUTIC RANGE IS 2-3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 287443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ATENOLOL 50 MG| FLOMAX 4 MG| WARFARIN| PANTOPRAZOLE 40 MG| GEMFIBROZIL 600 MG| CRESTOR 40 MG |