FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1923629
·
Received December 10, 2010
Report
- Report Number
- 2027969-2010-02150
- Event Type
- Injury
- Date Received
- December 10, 2010
- Date of Event
- November 18, 2010
- Report Date
- December 10, 2010
- 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
- AL, US
- Reporter Occupation
- NURSE
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: >7.5, LAB: 3.0. PT WAS GIVEN VITAMIN K DUE TO HIGH INR RESULT. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 235770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |