FDA Adverse Event
Other
Summary report: N
ALERE INRATIO PT/INR MONITORING SYSTEM
MDR report key: 4438989
·
Received January 14, 2015
Report
- Report Number
- MW5040308
- Event Type
- Other
- Date Received
- January 14, 2015
- Report Date
- January 14, 2015
- Manufacturer
- ALERE
- Product Code
- GJS
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RECEIVED LETTER ABOUT CONDITIONS THAT INSTRUMENT MAY NOT BE USED DURING THESE CONDITIONS. FOLLOWING INSTRUCTIONS OF WARNING LETTER TO REPORT ONLINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34292 | ALERE INRATIO PT/INR MONITORING SYSTEM | ALERE INRATIO PT/INR MONITORING SYSTEM | GJS | ALERE | 28184 | REV A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |