FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1942190
·
Received December 21, 2010
Report
- Report Number
- 2027969-2010-02223
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 22, 2010
- Report Date
- December 21, 2010
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: PATIENT 1: DATE: (B)(6) 2010, INRATIO: 1.6, LAB: 2.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 232888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |