FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX9 ALX CLINICAL SYSTEM
MDR report key: 2091507
·
Received May 17, 2011
Report
- Report Number
- 2050012-2011-01592
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 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
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND CLEANED THE SPILLAGE. FSE COULD NOT FIND THE CAUSE OF THE LEAK BUT CLEANED THE DRAIN SYSTEM. THERE WERE NO FURTHER COMPLAINTS TO DATE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE SYNCHRON CX9 ALX CLINICAL SYSTEM WAS LEAKING FROM THE HYDROCANISTER AREA AND FRONT OF THE INSTRUMENT ON THE FLOOR. PER CUSTOMER, THE LEAK APPEARED TO BE CREATININE (CRE) REAGENT. 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 |