FDA Adverse Event
Malfunction
Summary report: N
CNRATIO2 PT/INR PROFESSIONAL TEST STRIP
MDR report key: 3972866
·
Received April 28, 2014
Report
- Report Number
- 2027969-2014-00375
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- April 7, 2014
- Report Date
- April 8, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K110212
- Removal / Correction Number
- 2027969-04/16/14-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT HIGH INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO2 INR: 7.2, LABORATORY INR: 2.2, THERAPEUTIC RANGE: 2.0-3.0. THE TIME BETWEEN TESTING WAS WITHIN MINUTES. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253487 | CNRATIO2 PT/INR PROFESSIONAL TEST STRIP | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 99008G2 | 336426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INRATIO MONITOR SN #: (B)(4)| COUMADIN |