FDA Adverse Event
Summary report: N
INRATIO
MDR report key: 2013121
·
Received March 1, 2011
Report
- Report Number
- 2027969-2011-00415
- Date Received
- March 1, 2011
- Date of Event
- December 28, 2010
- Report Date
- February 28, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS FOR TWO PTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: PT #1: DATE (B)(6) 2010, INRATIO >7.5, THERAPEUTIC RANGE (NOT PROVIDED); DATE (B)(6) 2010, LAB 3.3. PT 2: DATE (B)(6) 2010, INRATIO >7.5, LAB 4.3, THERAPEUTIC RANGE (NOT PROVIDED). NO INFORMATION ON PT#2'S CONDITIONS OR MEDICATIONS WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 237431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |