FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2132429
·
Received June 13, 2011
Report
- Report Number
- 2027969-2011-01327
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 11, 2011
- Report Date
- June 13, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- 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 REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 7.5, REFERENCE (DOCTOR'S METER): 4.9. DATE: (B)(6) 2011, INRATIO: 5.7, REFERENCE (DOCTOR'S METER): 3.0. HIS TARGET IS 2.0-3.0. HE CONFIRMED HE HAD BEEN HAVING ISSUES WITH TESTING ON HIS METER, GETTING ERRORS NES BUT BLOOD WAS FULL IN ALL 3 CHANNELS. HE HAD BEEN TESTING ON THE METER FOR ABOUT 4-5 YRS NOW AND NEVER HAD ISSUES WITH HIGH RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 248203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |