FDA Adverse Event
Malfunction
Summary report: N
TRIAGE D-DIMER TEST
MDR report key: 1203148
·
Received October 8, 2008
Report
- Report Number
- 2027969-2008-00028
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Report Date
- October 10, 2008
- Manufacturer
- BIOSITE, INC.
- Product Code
- DAP
- PMA / PMN Number
- K042890
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS PENDING.
Description of Event or Problem · 1
FALSE NEGATIVE RESULTS WITH TRIAGE D-DIMER TEST ON PATIENT LATER DIAGNOSED WITH DEEP VEIN THROMBOSIS (DVT). NO FURTHER INFORMATION PROVIDED REGARDING PATIENT HISTORY AND CLINICAL PRESENTATION, AND OTHER PROCEDURES DONE FOR PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE D-DIMER TEST | D-DIMER TEST | DAP | BIOSITE, INC. | 98100 | W42880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |