FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 2190286
·
Received July 19, 2011
Report
- Report Number
- 2027969-2011-01585
- Event Type
- Injury
- Date Received
- July 19, 2011
- Date of Event
- June 15, 2011
- Report Date
- July 19, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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) 2011, INRATIO: 3.5; DATE: (B)(6) 2011, INRATIO: 2.5, LAB: 8.29. PT'S THERAPEUTIC RANGE: 2-3 INR. PT'S COUMADIN WAS HELD FOR 2 DAYS DUE TO METER READING ON (B)(6) 2011. HE WAS RETESTED 2 DAYS LATER. NURSE STATES THAT PT WAS MODERATELY BLEEDING, WHICH EVENTUALLY STARTED TO GET HEAVIER SO HE WAS SENT TO THE ER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 253025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| O |