FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS
MDR report key: 1914262
·
Received December 3, 2010
Report
- Report Number
- 2050012-2010-01430
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 5, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- LEG
- PMA / PMN Number
- K060256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
QC WAS RUN PRIOR TO THE EVENT AND THE RESULTS WERE WITHIN ESTABLISHED RANGES. BCI CUSTOMER CONTACT REPRESENTATIVE DISCUSSED THIS ISSUE WITH THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW VALPROIC ACID (VPA) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEMS FOR ONE PATIENT. THE INITIAL VPA RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. TWO RE-DRAW SAMPLES WERE COLLECTED; HOWEVER THE INSTRUMENT STILL YIELDED INCONSISTENT RESULTS. THE CUSTOMER SENT ONE SAMPLE TO A DIFFERENT LAB AND A HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED. PHYSICIAN DID NOT BELIEVE THE RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | LEG | BECKMAN COULTER INC. | DXC 600I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |