FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 2212990
·
Received August 8, 2011
Report
- Report Number
- 2027969-2011-01752
- Event Type
- Injury
- Date Received
- August 8, 2011
- Date of Event
- July 10, 2011
- Report Date
- August 8, 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
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER. CALLER IS THE DAUGHTER OF PT SELF TESTER WHO HAS BEEN TESTING HER MOTHER USING THE INRATIO METER. PT WAS RECENTLY IN THE HOSPITAL ON AN UNRELATED ISSUE AND WAS DISCHARGED ON (B)(6) 2011. PT WAS TAKING ANTIBIOTICS UP UNTIL (B)(6) 2011. PT WAS PUT ON BOTH COUMADIN AND LOVENOX ON (B)(6) 2011. NO SIGNS OF BLEEDING OR BRUISING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |