FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1891002
·
Received October 29, 2010
Report
- Report Number
- 2027969-2010-01837
- Event Type
- Other
- Date Received
- October 29, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 29, 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
- VT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" (B)(6) 2010, INR = 1.3; (B)(6) 2010, INR = 4.1; INR = 1.2 (FEW DAYS PRIOR TO (B)(6) 2010); INR = 5.3 (A FEW DAYS PRIOR - ACTUAL DATES NOT PROVIDED). THE DOCTOR HAD BEEN ADJUSTING COUMADIN DOSE. NO LAB COMPARISONS DONE AT TIME COMPLAINT WAS CALLED IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 235793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |