FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1949231
·
Received December 29, 2010
Report
- Report Number
- 2027969-2010-02292
- Event Type
- Other
- Date Received
- December 29, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 28, 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: "LAST WEEK"; INRATIO: 1.5. DATE: (B)(6) 2010; INRATIO: 6.5. PATIENT'S INR NORMALLY AROUND 2.1 TO 2.5. AFTER 1.5 INR LAST WEEK DOCTOR ADJUSTED COUMADIN DOSE. PATIENT HAS HAD NOSEBLEEDS FOR SEVERAL DAYS. PATIENT HAS BEEN TAKING ANTIBIOTICS FOR THE PAST 5 DAYS DUE TO A SINUS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 235737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |