FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM
MDR report key: 1941569
·
Received December 29, 2010
Report
- Report Number
- 2050012-2010-01763
- Event Type
- Malfunction
- Date Received
- December 29, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 1, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGES. THE CUSTOMER FOUND BUBBLES IN THE CO2 ACID REAGENT LINE. THE CUSTOMER RESEATED CAP, STRAWS AND TUBING AND PRIMED TO REMOVE THE BUBBLES. THIS RESOLVED THE ISSUE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW CARBON DIOXIDE (CO2) RESULTS GENERATED BY UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED HIGHER RESULTS, WHICH WERE REPORTED. THERE WAS NO EFFECT TO THE PATIENTS OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMSTRY ANALYZER | JJE | BECKMAN COULTER, INC. | DXC 800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |