FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1749481
·
Received June 29, 2010
Report
- Report Number
- 2027969-2010-00849
- Event Type
- Malfunction
- Date Received
- June 29, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 29, 2010
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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: NG, INRATIO: 2.3, LAB: NG; 3.0, NG; (B)(6) 2010, 6.1, 3.2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | BIOSITE INCORPORATED | 100139 | 232170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |