FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3082580
·
Received April 24, 2013
Report
- Report Number
- 2027969-2013-00335
- Event Type
- Malfunction
- Date Received
- April 24, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 24, 2013
- Manufacturer
- ALERE SAN DIEGO INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGING DISCREPANT LOW READING ON ONE PATIENT/METER/LOT. INRATIO: 1.5, LAB: 2-3. TIME BETWEEN TESTING 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176171 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO INC. | 100139 | 297453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COUMADIN |