FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2201028
·
Received July 1, 2011
Report
- Report Number
- 2027969-2011-01459
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- June 27, 2011
- Report Date
- July 1, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING. TESTING WAS PERFORMED ON BOTH THE INRATIO AND INRATIO2. THE 510 (K) NUMBER LISTED IS FOR THE INRATIO. THE 510 (K) NUMBER FOR THE INRATIO2 IS K072727.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: >7, INRATIO2: 7.3, LAB: 4.1. CUSTOMER HAS BEEN GETTING DISCREPANT HIGH RESULTS ON SEVERAL PTS. THIS PT HAS BEEN EATING PLENTY OF SALADS AND GREENS. NO OTHER DATA PROVIDED FOR THE OTHER PTS. SEVERAL PTS HAD THEIR COUMADIN DOSE CHANGED BASED ON THE INRATIO RESULTS. CALLER TESTED HERSELF YESTERDAY (NON-COUMADIN) INRATIO = 1.4; INRATIO2 = 1.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 251112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |