FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX9 ALX
MDR report key: 1564027
·
Received December 23, 2009
Report
- Report Number
- 2050012-2009-00137
- Event Type
- Malfunction
- Date Received
- December 23, 2009
- Date of Event
- December 3, 2009
- Report Date
- December 23, 2009
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- CGX
- PMA / PMN Number
- K950958
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE NOTICED CALIBRATION AND QC RESULTS FOR CREATININE WERE IMPRECISE. THE FSE REPLACED THE CREATININE MODULE AND PERFORMED A PREVENTIVE MAINTENANCE (PM). A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A FALSE LOW CREATININE CRE3) RESULT GENERATED BY THE SYNCHRON CX9 ALX ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 0.1 MG/DL. THE ORIGINAL SPECIMEN WAS RE-TESTED AND REPEATED CRE3 RESULT OF 0.8 MG/DL WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.
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 |