FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1960224
·
Received January 6, 2011
Report
- Report Number
- 2027969-2011-00035
- Event Type
- Other
- Date Received
- January 6, 2011
- Date of Event
- December 15, 2010
- Report Date
- January 6, 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
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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) 2010, INRATIO: 1.8; DATE: (B)(6) 2010, INRATIO: 1.9, 1.8, LAB: 8.4. PT CAME IN ON (B)(6) 2010, COMPLAINING ABOUT BRUISING ON HIS ARM. THEY COMPLETED A TEST ON THE METER AND GOT 1.8 INR; NO INFO IF PT WAS TESTED AT THE LAB ON THIS DAY. THEN PT CAME BACK TODAY FOR F/U CHECK UP AND PT COMPLAINED HIS ARM GOT WORSE; IT WAS VERY SWOLLEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 234591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |