FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX9 ALX CLINICAL SYSTEM
MDR report key: 2091517
·
Received May 17, 2011
Report
- Report Number
- 2050012-2011-01580
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K950958
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER IN REPOSITIONING TUBING AND DOING MULTIPLE CUP PRIMES AND CUP IS NOW DRAINING PROPERLY. PER CUSTOMER, THEY WOULD MONITOR AND CALL BACK IF NEEDED. THERE HAVE BEEN NO FURTHER COMPLAINTS TO DATE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE GLUCOSE (GLU) CUP OF THE SYNCHRON CX9 ALX CLINICAL SYSTEM WAS NOT DRAINING AND OVERFLOWED. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CX9 ALX CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |