FDA Adverse Event
Injury
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 3962468
·
Received July 11, 2014
Report
- Report Number
- 2027969-2014-00651
- Event Type
- Injury
- 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
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO A REFERENCE POINT OF CARE (POC) INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 2.9, POC INR: 7.4 AND 7.1. THERAPEUTIC RANGE: 2.5 - 3.0. THE TIME BETWEEN TESTING WAS ONE (1) HOUR. THE PATIENT'S WARFARIN WAS HELD BASED ON THE POC INR. THE FOLLOWING DAY, THE LABORATORY INR WAS 5.4. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. MANUFACTURER REPORT NUMBER 2027969-2014-00651
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408073 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 344096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | TOPIRAMATE 150MG IN AM/200MG IN PM| POTASSIUM 20MG| ALLBUTEROL AS NEEDED| COAGUCHECK| WARFARIN 10-12.5MG AS DIRECTED| LANTUS INSULIN 20UNITS| DETROL LA 4MG| DIFLUCAN 1 DOSAGE GIVEN TUESDAY ONLY| SIMVASTATIN 20MG DAILY| METFORMIN 500MG 2X DAILY| DOC-Q-LACEE 200MG| CIPRO 500MG DAILY| DAKTOZIN 20MG 4X DAILY| INRATIO MONITOR, SN 112054458 |