FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1843491
·
Received September 20, 2010
Report
- Report Number
- 2027969-2010-01508
- Event Type
- Injury
- Date Received
- September 20, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 20, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
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: 2 WEEKS AGO, INRATIO: 5.2, LAB: 3.5. ABOUT 2 HOURS DIFFERENCE BETWEEN METER AND DRAW TIME. PATIENT DID EXPERIENCE BRUISING AND BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 232171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |