FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1881279
·
Received October 18, 2010
Report
- Report Number
- 2027969-2010-01755
- Event Type
- Malfunction
- Date Received
- October 18, 2010
- Date of Event
- September 29, 2010
- Report Date
- October 18, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER REPORTS DISCREPANT RESULTS WITH METER. DATE: (B)(6) 2010, INRATIO: 1.7, RETEST INRATIO: 1.2. PT CLAIMS THAT INR RESULTS AT THE DOCTOR'S OFFICE WERE HIGHER AND WITHIN THE TARGET RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |