FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1853389
·
Received September 27, 2010
Report
- Report Number
- 2027969-2010-01503
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 20, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: (B)(6) 2010; INRATIO: >7.5; LAB: 2.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |