FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 2009115
·
Received February 22, 2011
Report
- Report Number
- 2027969-2011-00376
- Event Type
- Other
- Date Received
- February 22, 2011
- Date of Event
- January 27, 2011
- Report Date
- February 21, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: >7.5 (CUSTOMER CALLED BACK ON (B)(6) 2011 AND STATED THAT THIS PATIENT HAD COUMADIN WITHHELD OVER THE WEEKEND); (B)(6) 2011, LAB: 2.2. THERAPEUTIC RANGE IS 2.0-3.0. NURSE TESTED HERSELF USING A DIFFERENT METER AND NEW STRIP LOT 243103; GOT 1.0. TESTED AGAIN ON SAME FINGER USING METER IN THIS CASE AND ORIGINAL STRIP LOT 232886; GOT 1.5. NURSE HAS HAD A COLD AND IS TAKING ASPIRIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 232886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |