FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2010238
·
Received February 11, 2011
Report
- Report Number
- 2027969-2011-00294
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 14, 2011
- Report Date
- February 10, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.2, LAB: 2.2. (B)(6) 2011, 2.2, 1.7. THE STRIP LOT FOR TESTING ON (B)(6) 2011 WAS NOT KNOWN. TESTING ON (B)(6) 2011 USED STRIP LOT #243934. ALL TESTING WAS DONE WITHIN AN HOUR ON THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |