The complainant is a laboratory supervisor. The complainant indicated that the advia centaur system was used to determine psa. The complainant states that on the previous day all the psa control results were within range. The lab continued to run psa throughout the day. That evening they ran about 60 psa tests and received values between 4-82. The next day the controls were again run and were all out of range with an approximate 20 sd. They repeated the controls and they were within range. The laboratory started to receive calls about psa results. They repeated all psa tests from the previous day and samples that were between 4-82 are now less than 4. One patient, based on an elevated psa result did receive chemotherapy when in fact the result was low. An field engineer is being dispatched to the facility to reiew the operation of the system. A follow-up report will be provided once the on-site evaluation is complete.

A field engineer was dispatched to the account. Upon arrival several items within the instrument were repaired and inspected. For example the acid probe tubing was properly aligned and secured. The vacuum line gong to aspirate probes had a "pinched memory" and was corrected. The wash dispense port has large droplets of water around it. To correct this situation the separation manifold was removed and cleaned. The base probe for signal errors was replaced as a preventative measure. It is believed that the root cause of the discrepant results was twofold. The first was a crimped vacuum line and the customers frequency of control evaluation. The field engineer again reviewed the need and frequency for running controls to verify system performance. The complaint is considered closed for purposes of mdr.