FDA Adverse Event
Malfunction
Summary report: N
PLAC
MDR report key: 4540913
·
Received February 18, 2015
Report
- Report Number
- MW5040842
- Event Type
- Malfunction
- Date Received
- February 18, 2015
- Report Date
- February 18, 2015
- Manufacturer
- DIADEXUS, LLC
- Product Code
- NOE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESULTS FROM THE TEST VARY GREATLY FROM LAB TO LAB MAKING IT HARD FOR MY DOCTOR TO TELL IF I AM AT RISK OR NOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117994 | PLAC | PLAC | NOE | DIADEXUS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |