FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2231298
·
Received July 25, 2011
Report
- Report Number
- 2027969-2011-01623
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 27, 2011
- Report Date
- July 25, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)64) 2011, INRATIO: 1.5, RETEST #1: 5.3, RETEST #2: 1.9. PT'S TARGET RANGE IS 2.0 - 3.0. RESULTS DONE WITHIN MINUTES OF EACH OTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 243104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |