FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1913786
·
Received November 23, 2010
Report
- Report Number
- 2027969-2010-02034
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 31, 2010
- Report Date
- November 23, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2010, INRATIO: 2.0. DATE: (B)(6) 2010, 3.1. DATE: (B)(6) 2010, 4.5, (LOT# 233708). DATE: (B)(6) 2010, 2.6, (LOT# 225323). DATE: (B)(6) 2010, 4.5, (LOT# 233708). DATE: (B)(6) 2010, 3.5, (LOT# 225323). DATE: (B)(6) 2010, 4.3, (LOT# 235740). PT'S TARGET 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 | 233708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |