FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2231035
·
Received July 19, 2011
Report
- Report Number
- 2027969-2011-01580
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 13, 2011
- Report Date
- July 19, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- 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) 2011, INRATIO: 6.9, LAB: 4.7. DATE: (B)(6) 2011, INRATIO: 5.1. THE PATIENT'S THERAPEUTIC RANGE IS BETWEEN 2.0 AND 3.4. THE TIME BETWEEN TESTING WAS BETWEEN FIFTEEN AND TWENTY MINUTES. SHE TOOK HER LAST DOSE OF COUMADIN ON (B)(6). THE PATIENT'S RESULT WAS HIGHER THAN USUAL, SO SHE HELD OFF ON TAKING HER COUMADIN UNTIL (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |