FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1804693
·
Received August 6, 2010
Report
- Report Number
- 2027969-2010-01150
- Event Type
- Malfunction
- Date Received
- August 6, 2010
- Date of Event
- July 16, 2010
- Report Date
- August 6, 2010
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- GJS
- PMA / PMN Number
- K0201923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTED DISCREPANT RESULTS: UNKNOWN LOT WAS USED FOR METER TEST ON (B)(6) 2010. LOT #233708 WAS USED FOR METER TESTS ON (B)(6) 2010 AND (B)(6) 2010. VENOUS BLOOD WAS USED ON THE METER ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | BIOSITE INCORPORATED | 100007 | 233708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |