UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM
Report
- Report Number
- 2050012-2011-04646
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- November 20, 2008
- Report Date
- November 20, 2008
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE SYSTEM WAS EVALUATED BY A BCI FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE CL CALIBRATION HAD FAILED. THE FSE REPLACED THE CL ELECTRODE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT AND THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE ERRONEOUS RESULTS WERE RERUN ON A SYNCHRON LX20 SYSTEM AND WERE CONSIDERED NORMAL. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES.
THE SYSTEM WAS EVALUATED BY A BCI FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE CL CALIBRATION HAD FAILED. THE FSE REPLACED THE CL ELECTRODE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT AND THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE ERRONEOUS RESULTS WERE RERUN ON A SYNCHRON LX20 SYSTEM AND WERE CONSIDERED NORMAL. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES.
THE SYSTEM WAS EVALUATED BY A BCI FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE CL CALIBRATION HAD FAILED. THE FSE REPLACED THE CL ELECTRODE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT AND THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE ERRONEOUS RESULTS WERE RERUN ON A SYNCHRON LX20 SYSTEM AND WERE CONSIDERED NORMAL. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES.
H3, H6: THE SYSTEM WAS EVALUATED BY A BCI FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE CL CALIBRATION HAD FAILED. THE FSE REPLACED THE CL ELECTRODE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT AND THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE ERRONEOUS RESULTS WERE RERUN ON A SYNCHRON LX20 SYSTEM AND WERE CONSIDERED NORMAL. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES.
H3, H6: THE SYSTEM WAS EVALUATED BY A BCI FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE CL CALIBRATION HAD FAILED. THE FSE REPLACED THE CL ELECTRODE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT AND THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE ERRONEOUS RESULTS WERE RERUN ON A SYNCHRON LX20 SYSTEM AND WERE CONSIDERED NORMAL. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES.
H3, H6: THE SYSTEM WAS EVALUATED BY A BCI FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE CL CALIBRATION HAD FAILED. THE FSE REPLACED THE CL ELECTRODE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT AND THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE ERRONEOUS RESULTS WERE RERUN ON A SYNCHRON LX20 SYSTEM AND WERE CONSIDERED NORMAL. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM | JJE | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | |||
| 2 | 56 YR | |||
| 3 | 68 YR | |||
| 4 | 75 YR | |||
| 5 | 72 YR | |||
| 6 | 68 YR |