FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1911447
·
Received November 22, 2010
Report
- Report Number
- 2027969-2010-02028
- Event Type
- Other
- Date Received
- November 22, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 22, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: UNK, INRATIO: 1.9. DATE: "NEXT DAY", LAB: 5.0. PT METER RESULTS WERE CONSIDERED LOW BY DOCTOR, SO COUMADIN DOSE WAS INCREASED. METER RESULTS STILL LOW, SO PT DECIDED TO HAVE LABS DRAWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 235738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |