FDA Adverse Event
Malfunction
Summary report: N
INRATIO2 PT/INR PROFESSIONAL TEST STRIP
MDR report key: 3963497
·
Received May 30, 2014
Report
- Report Number
- 2027969-2014-00509
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 7, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K110212
- Removal / Correction Number
- Z-1564-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO2 INR: 1.9. LABORATORY INR: 2.6. THERAPEUTIC RANGE: 2.5 - 3.5. THE TIME BETWEEN TESTING WAS THIRTY (30) MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320224 | INRATIO2 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 UNK| WARFARIN |