FDA Adverse Event
Malfunction
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 4170541
·
Received July 11, 2014
Report
- Report Number
- 2027969-2014-00650
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 20, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LAB INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR: 1.8. LAB INR: 5.6. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS ONE (1) HOUR. REPORTEDLY, THE MONITOR WAS NOT IN THE CORRECT MODE WHEN THE FINGER STICK WAS PERFORMED AND THE FINGER WAS "MILKED" AFTER THE FINGER STICK. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408424 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 345312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INRATIO MONITOR SN# (B)(4)| WARFARIN 10MG M/W/F AND 15MG T/TH/SA/SU |