FDA Adverse Event
Malfunction
Summary report: N
INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE
MDR report key: 3231079
·
Received July 12, 2013
Report
- Report Number
- 2027969-2013-00568
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 21, 2013
- Report Date
- July 11, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT ACCURACY RESULTS WHEN COMPARED TO THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 1.8, LAB: 2.9. TIME BETWEEN TESTING WAS REPORTED AS A COUPLE OF MINUTES. PT'S THERAPEUTIC RANGE IS 2.5 - 3.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321956 | INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 305773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PRILOSEC| AMIODARONE| RESTORIL| GIBRAMYCIN| WARFARIN| LASIX| LOVENOX| COREG| AMLODIPINE| LIPITOR| LISINOPRIL |