FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 1924796
·
Received December 10, 2010
Report
- Report Number
- 2027969-2010-02156
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 22, 2010
- Report Date
- December 10, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. PT HAD A NOSEBLEED THE NIGHT OF (B)(6) 2010, WHICH STOPPED WITHOUT TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |