FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2243860
·
Received July 29, 2011
Report
- Report Number
- 2027969-2011-01680
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 29, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 3.8; LAB: 3.0. LAB DRAW DONE RIGHT AFTER METER TEST. PT SELF TESTER HAS BEEN USING THE METER SINCE (B)(6) 2008. PT ALSO STATED WHEN SHE HAD PERFORMED CORRELATIONS IN THE PAST, THE METER CORRELATED WELL WITH THE LAB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 254609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |