FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1973813
·
Received January 13, 2011
Report
- Report Number
- 2027969-2011-00100
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- December 19, 2010
- Report Date
- January 13, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER (PT'S WIFE) ALLEGED IMPRECISION WITH INRATIO METER. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. ON (B)(6) 2010, PT'S WIFE ADJUSTED HIS COUMADIN. PT WAS BLEEDING IN THE MOUTH SOME TIME AGO AND HIS WIFE COULD NOT CONTACT THE PHYSICIAN RIGHT AWAY, SO THEY DECIDED TO ADJUST HIS COUMADIN DOSE AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 237411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |