FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1973091
·
Received January 19, 2011
Report
- Report Number
- 2027969-2011-00136
- Event Type
- Other
- Date Received
- January 19, 2011
- Date of Event
- December 13, 2010
- Report Date
- January 19, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 2.5; DATE: (B)(6) 2010, LAB: 7.5. ON (B)(6), PT WENT TO HOSPITAL BECAUSE OF A HEMATOMA ON HER SHOULDER. INR IN HOSPITAL (VENIPUNCTURE) WAS 7.5. SHE WAS GIVEN VITAMIN K AND TAKEN OFF COUMADIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 216970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |