FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 2211354
·
Received August 2, 2011
Report
- Report Number
- 2027969-2011-01709
- Event Type
- Other
- Date Received
- August 2, 2011
- Date of Event
- July 6, 2011
- Report Date
- August 2, 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
- NJ, 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: 5.9, LAB: 3.1. LAST WEEK THE PT HAD AN INR OF 5.9 AND WAS SYMPTOMATIC OF HIGH INR (SHE HAD BRUISING AND BLEEDING). THEY DID LOWER HER COUMADIN DOSAGE. PT'S THERAPEUTIC RANGE IS 2.0-3.0. PT IS TAKING TWO NEW MEDICATIONS, BUT THE NURSE DIDN'T KNOW WHAT THEY WERE. PT IS ANEMIC AND DOES HAVE CANCER; NURSE IS NOT SURE OF HEMATOCRIT LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 251112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |