FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1856618
·
Received October 1, 2010
Report
- Report Number
- 2027969-2010-01639
- Event Type
- Other
- Date Received
- October 1, 2010
- Date of Event
- June 16, 2010
- Report Date
- October 1, 2010
- Manufacturer
- ALERE SAN DIEGO INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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. IN MAY, PATIENT'S COUMADIN DOSE WAS AROUND 5 MGS A DAY. DOSAGE WAS INCREASED DUE TO LOW READINGS ON INRATIO. IN JUNE, COUMADIN ENDED UP BEING INCREASED TO 10 MGS AT A TIME. ON JUNE 16TH, PATIENT (WHO IS BED RIDDEN) WENT FOR A ROUTINE CHECK UP AND LAB INR = 7.49. PATIENT WAS TAKEN OFF COUMADIN AND DOSAGE WAS TAKEN BACK DOWN TO 1 MG PER DAY. ON AUGUST 25TH COUMADIN DOSAGE WAS INCREASED FROM 1 MG PER DAY TO 6 MGS PER DAY AFTER INR = 1.4. SEPTEMBER 8TH, INR = 1.3. CARETAKER WAS CONCERNED THAT INR VALUES DO NOT CHANGE WITH DOSAGE CHANGE. PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |