FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1941851
·
Received December 22, 2010
Report
- Report Number
- 2027969-2010-02251
- Event Type
- Injury
- Date Received
- December 22, 2010
- Date of Event
- November 29, 2010
- Report Date
- December 22, 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
- CO, US
- Reporter Occupation
- NOT APPLICABLE
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: 1.6, LAB: NG. DATE: (B)(6) 2010, INR: 1.4, LAB: 2.3. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR. PT'S COUMADIN DOSE WAS INCREASED ON (B)(6) 2010 AND PT WAS THEN PUT ON LOVENOX ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 234587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |