COBAS 8000 C 502 MODULE

Description of Event or Problem

WE NOTICED A SPORADIC QUALITY CONTROL PROBLEM FOR URINE MICROALBUMIN AND ALSO URINE TOTAL PROTEIN. WE RAN A PRECISION STUDY AND IT FAILED. WE CALLED SERVICE AND THEY FOUND A FAILING "GEAR PUMP" WHICH RINSES OUT THE SAMPLE PIPETTE (ITS FAILURE WAS INTERMITTENT). WHEN IT FAILED, IT DID NOT RINSE SERUM OUT OF THE PIPETTE, AND IT AFFECTED URINE TESTS SINCE THERE IS 1000 TIMES AS MUCH PROTEIN IN SERUM AS IN URINE. THE PUMP IS REPLACED EVERY THREE YEARS ON A SCHEDULE, BUT THIS ONE WAS REPLACED A YEAR AGO, SO IT FAILED MUCH SOONER THAN ANTICIPATED. ADDITIONALLY, THIS IS NOT AN ITEM THE LAB STAFF CAN ACCESS. AFTER THE REPAIR, WE LOOKED BACK AND PULLED 150 SAMPLES RUN SINCE THE PROBLEM APPEARS TO HAVE BEGUN. WE REPEATED ALL OF THE TESTING AND FOUND 21 SAMPLES HAD BEEN REPORTED IN ERROR. ALL WERE FALSELY ELEVATED (I.E. FALSE POSITIVES). WE MADE CORRECTED REPORTS AND NOTIFIED THE PHYSICIANS.