FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1864892
·
Received October 6, 2010
Report
- Report Number
- 2027969-2010-01629
- Event Type
- Other
- Date Received
- October 6, 2010
- Date of Event
- September 9, 2010
- Report Date
- October 6, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. PATIENT #1: DATE: (B)(6) 2010; INRATIO: 4.4; RETEST INRATIO: 2.6; LAB: 4.0. HAD A 1.5 INR A WEEK PRIOR AND COUMADIN DOSE MAY HAVE BEEN CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 235793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |