FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1973812
·
Received January 13, 2011
Report
- Report Number
- 2027969-2011-00099
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- December 20, 2010
- Report Date
- January 13, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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: 5.9, LAB: 3.7. DATE: (B)(6) 2010, INRATIO: 3.3, LAB: NG. ON (B)(6) 2010, PT OBSERVED HEMORRHAGING IN THE EYE AND WENT TO THE DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |