FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3243032
·
Received July 18, 2013
Report
- Report Number
- 2027969-2013-00582
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 28, 2013
- Report Date
- July 1, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED. INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013; INRATIO INR: 1.8; LABORATORY INR: 6.0. THE TIME BETWEEN TESTING WAS WITHIN ONE HOUR. THERAPEUTIC RANGE 1.5 - 2.5 FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335437 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 304239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COUMADIN| TWO UNSPECIFIED ANTIBIOTICS |