FDA Adverse Event
Other
Summary report: N
SYNCHRON LX20
MDR report key: 449845
·
Received March 18, 2003
Report
- Report Number
- 2050012-2003-00004
- Event Type
- Other
- Date Received
- March 18, 2003
- Date of Event
- February 11, 2003
- Report Date
- March 18, 2003
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A CUSTOMER RAN A PATIENT SAMPLE OFF A RED TOP SERUM SAMPLE FROM ER. THE PHENYTOIN (PHY) RESULT WAS 1.7 UG/ML. THIS RESULT WAS BELOW THE ANALYTICAL RANGE. NO HISTORY AVAILABLE. CUSTOMER PERFORMED 3 MORE RERUNS OF THE SAMPLE AND THE RESULTS WERE: <0.1 UG/ML, 20.1 UG/ML AND 19.3 UG/ML. CUSTOMER REPORTED OUT THE RESULT OF 19.3 UG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX20 | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER, INC. | SYNCHRON LX20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |