FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1963391
·
Received January 10, 2011
Report
- Report Number
- 2027969-2011-00064
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 13, 2010
- Report Date
- January 10, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: "A WEEK AGO", INRATIO: 3.7. (B)(6) 2010, 1.5, RETEST INRATIO: 2.6. PATIENT IS A (B)(6) BOY ON COUMADIN DUE TO DUAL MECHANICAL HEART VALVES. PATIENT'S TARGET THERAPEUTIC RANGE IS 3.0-4.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |