FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2190062
·
Received June 29, 2011
Report
- Report Number
- 2027969-2011-01432
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 29, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, 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: 1.9, 2.0, LAB MONITOR: 2.7, LAB DRAW: 3.3. THERAPEUTIC RANGE: 2.0-3.0. TESTER REPORTED AT 8:30AM, HIS METER READ 1.9. ONE HOUR LATER, HE WENT TO THE LAB AND HIS METER READ 2.0 WHILE THE LAB MONITOR READ 2.7; 10 MINUTES LATER, HE GOT A LAB DRAW AND THE RESULTS WERE 3.3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |