FDA Adverse Event
Injury
Summary report: N
INRATIO2
MDR report key: 2038550
·
Received March 23, 2011
Report
- Report Number
- 2027969-2011-00579
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 23, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- 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 USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011; PATIENT 1: INRATIO: >7.5. DATE: (B)(6) 2011; PT: 2; INRATIO: 5.0-6.0; LAB: 4.3. PT 1 WAS GIVEN VITAMIN K. PT 2 - WHEN REPORTING THE LAB RESULT ON (B)(6) 2011, THE NURSE WAS NOT SURE IF THE INRATIO INR WAS CLOSER TO 5.0, OR 6.0 AS ORIGINALLY STATED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 237432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |