FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX9 ALX
MDR report key: 1978121
·
Received February 3, 2011
Report
- Report Number
- 2050012-2011-00269
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 6, 2011
- Report Date
- January 6, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- CGX
- PMA / PMN Number
- K950958
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER CUSTOMER, CALIBRATION AND QC WAS ACCEPTABLE AT THE BEGINNING OF THE SHIFT. A FIELD SERVICE ENGINEER (FSE) REPLACED THE CREATININE MODULE. A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN.
Description of Event or Problem · 1
CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING FALSE HIGH CREATININE MODULE RESULT GENERATED BY THE SYNCHRON CX9 ALX ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LAB AND THE CUSTOMER DOES NOT HAVE THE INFORMATION FOR THE ERRONEOUS RESULTS. PATIENT TREATMENT WAS NOT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CX9 ALX | CLINICAL CHEMISTRY ANALYZER | CGX | BECKMAN COULTER INC. | CX9 ALX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |