FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2082698
·
Received April 28, 2011
Report
- Report Number
- 2027969-2011-00954
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 28, 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
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 2.0, LAB: 2.6. NOT GIVEN, 1.9, 2.2. NOT GIVEN, 2.1, 2.4. CALLER HAS HAD METER FOR A LONG TIME AND ISSUE NOTICED SINCE THE BEGINNING OF THE YEAR. CALLER TESTS EVERY THREE WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |