FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2864632
·
Received December 6, 2012
Report
- Report Number
- 2027969-2012-01668
- Event Type
- Malfunction
- Date Received
- December 6, 2012
- Date of Event
- November 13, 2012
- Report Date
- December 6, 2012
- Manufacturer
- ALERE SAN DIEGO INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Adverse Event
- Yes
- 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
PATIENT SELF TESTER DISCREPANT LOW INRATIO READING: (B)(6) INRATIO = 2.4, LAB = 4.4 - 90 MINUTES LATER. PATIENT SELF TESTER ADMITTED TO HOSPITAL FOR RECTAL BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME | GJS | ALERE SAN DIEGO INC | 100071 | 293019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | HYDROCHLOROTHIAZIDE| ISOSORBIDE| LOSARTAN| COUMADIN| PREDNISONE| PRAVASTATIN |