FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2213871
·
Received August 5, 2011
Report
- Report Number
- 2027969-2011-01741
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 6, 2011
- Report Date
- August 5, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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: 5.0, DOCTOR'S COAGUCHECK: 3.9, PATIENT'S COAGUCHECK: 4.3. PT TESTED ON HER DOCTOR'S COAGUCHECK METER. TWO HOURS LATER, SHE CAME HOME AND TESTED ON THE INRATIO2 METER. PT ALSO HAS A COAGUCHECK METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 247451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |