FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2220095
·
Received August 12, 2011
Report
- Report Number
- 2027969-2011-01791
- Event Type
- Malfunction
- Date Received
- August 12, 2011
- Date of Event
- July 14, 2011
- Report Date
- August 12, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 4.0, 1.7, 2.8, 4.1, 1.3 AND 1.6. ALSO REPORTED NES AND ERROR 114 ON SAME LOT. PT IS HAVING DIFFICULTY OBTAINING SAMPLE AND IS MILKING FINGER. THERAPEUTIC RANGE 1.8-3.2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |