FDA Adverse Event
Other
Summary report: N
INRATIO2
MDR report key: 1943019
·
Received December 23, 2010
Report
- Report Number
- 2027969-2010-02280
- Event Type
- Other
- Date Received
- December 23, 2010
- Date of Event
- December 6, 2010
- Report Date
- December 23, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATING PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 'LO' ERROR; (B)(6) 2010, 1.8, 5.3. INRATIO TEST WAS PERFORMED WITHIN 5 MINUTES OF VENOUS DRAWS GOING OUT TO THE LAB. MEDICATION WAS INCREASED BASED ON RESULT OF "LO" ERROR ON (B)(6) 2010. PT WAS ON LOVENOX 11/23 TO 11/27 AS WELL AS COUMADIN, DAILY ASPIRIN, AND AMOXICILLIN. CUSTOMER GOT A 1.2 AND 1.0 AFTER TESTING HERSELF ON TWO DIFFERENT METERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 234590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |