Advertisement
System Misinterprets Wash 1 Fluid Signals
Assay Type
Thyroid
If the system indicates that the Wash 1 bottle and reservoir is empty, the system will stop
processing samples.
Siemens does not recommend a review of past results because the issue can be detected by
reviewing quality control (QC) results, and by visually checking the amount of fluid in the
Wash 1 bottle. In addition, both the Wash 1 bottle and the Wash 1 reservoir must be empty for
the system to fail to detect an empty Wash 1 bottle and reservoir and continue sampling.
Risk to Health
If the system does not detect the absence of Wash 1 fluid, and sample processing continues,
erroneous but believable results can be reported for assays that use Wash 1. The overall risk of
patient impact is low given other biomarkers, imaging results, patient history, clinical signs and
symptoms used in conjunction with the result to manage patient treatment.
If the system incorrectly reports that there is no fluid in the tubing when there is actually fluid in
the tubing, the system displays either a yellow Supplies Status warning indicating that the
system is running on reserve, or a red error message indicating that fluid is depleted and the
system is going to stop sampling. This case has no affect on results.
Actions to be Taken by the Customer
Please use the actions below to address the following issues:
The system fails to detect that the Wash 1 bottle and reservoir are empty and continues to
1.
process samples.
The system stops processing samples even though there is sufficient Wash 1 present in the
2.
Wash 1 bottle and reservoir.
System Fails to Detect Empty Wash 1 Bottle and Reservoir
•
Do not use the status information on the User Interface (UI) workspace to monitor the
amount of fluid in the Wash 1 bottle. Periodically check the amount of fluid in the Wash 1
bottle and use the instructions below to replace the Wash 1 bottle before it becomes
depleted.
•
Replace the Wash 1 Bottle Before Depletion:
CAUTION: Replace the Wash 1 bottle before the solution is depleted. If the bottle is
depleted for a period of time, and the Supplies Status button does not display yellow to
warn operators of this condition, the reservoir may become empty. The system may
report erroneous results since the system did not deliver Wash 1 solution to the cuvettes
during analysis.
Replace the Wash 1 bottle when the fluid level is just below the label on the bottle.
Refer to Replacing System Fluids in the ADVIA Centaur XP Operator's Guide or
ADVIA Centaur Operator's Guide for additional instructions.
Urgent Field Safety Notice 10813924, Rev. A – November 2012
GPF-003-11 V1.0 Effective: September 21, 2012
Related Procedure: GP-003 DX- Field Correction Action
Assay
TSH3UL
Page 2 of 5
Advertisement
