FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 1913516
·
Received November 24, 2010
Report
- Report Number
- 2027969-2010-02060
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 13, 2010
- Report Date
- November 24, 2010
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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: 3.5, 5.2, LAB: 2.9, 3.0. (PT NOT SURE ABOUT EXACT RESULT FOR 3.0 AND STATED "3 POINT SOMETHING"). "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 3.2, 5.0, 1.3. FIRST OR SECOND DROP USED WHEN THE FIRST DROP DOES NOT APPEAR LARGE ENOUGH. SELF-TEST (HUSBAND) = 1.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 233708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |