FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1908302
·
Received November 17, 2010
Report
- Report Number
- 2027969-2010-01982
- Event Type
- Other
- Date Received
- November 17, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 17, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. PT RECEIVED 2 LOVENOX INJECTIONS PRIOR TO A HERNIA SURGERY. AFTER THE SURGERY, PT RECEIVED CEPHALEXIN. COUMADIN DOSE INCREASED DUE TO 1.6 AND 1.9 INR RESULTS. PT WENT TO HOSPITAL WITH CHEST PAIN THAT TURNED OUT TO BE ANXIETY. INR NOTED TO BE 9.0 FROM LABS TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 233029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |