FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2230936
·
Received July 20, 2011
Report
- Report Number
- 2027969-2011-01591
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 20, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDL LOT#: 248203. PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 3.8, LAB: 2.0. PT'S TARGET THERAPEUTIC RANGE IS 2.0-2.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 254609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |