FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1978690
·
Received January 28, 2011
Report
- Report Number
- 2027969-2011-00201
- Event Type
- Other
- Date Received
- January 28, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 28, 2011
- Manufacturer
- ALERE SAN DIEGO
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 6.8, INRATIO: 5.6, LAB: 10.2. LAB DRAW WAS DONE AN HOUR AFTER INRATIO RESULTS. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.0-3.5. PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED VITAMIN K AFTER LAB OF 10.2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO | 100071 | 243699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |