FDA Adverse Event
Other
Summary report: N
IN RATIO 2
MDR report key: 4759367
·
Received April 7, 2015
Report
- Report Number
- MW5042589
- Event Type
- Other
- Date Received
- April 7, 2015
- Report Date
- March 24, 2015
- Manufacturer
- ALERE
- Product Code
- GJS
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPANY CONTACTED ME TELLING ME THERE HAD BEEN PROBLEMS WITH TESTING RESULTS WITH INFORMATION ON WHAT TO DO. I FOLLOWED DIRECTIONS INCLUDING TAKING INFO TO DOCTOR. I LOST THE RETURN FORM AND WAS CONTACTED BY ALERE AND WAS TOLD TO CONTACT YOU. I WAS NOT INJURED IN ANYWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229025 | IN RATIO 2 | P.T. INR MACHINE | GJS | ALERE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | PERCOCET| GEODON| METFORIMIN| SOMA| CYTOMEL| TOPROL| DYAZIDE| COUMADIN| PROTONICS| ZOCAR| KLONOPIN XANAX| VIT D| SYNTHROID| EFFEXOR |