FDA Adverse Event
Malfunction
Summary report: N
INRATION PT/INR TEST STRIPS
MDR report key: 3921928
·
Received May 28, 2014
Report
- Report Number
- 2027969-2014-00499
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 6, 2014
- Manufacturer
- ALERE SAN DIEGO INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR 5.7 AND 1.1. THERAPEUTIC RANGE: UNK. THE TIME BETWEEN TESTING WAS TEN (10) MINUTES. REPORTEDLY, THE PT'S FINGER WAS "MILKED". THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314898 | INRATION PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO INC | 100139 | 312576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INRATIO MONITOR SN (B)(4) |