COBAS 6000 C501MODULE

Description of Event or Problem

USER EXPERIENCED ISSUE WITH CONTROL RECOVERY AND HIGH RESULTS FOR PHOSPHORUS ON EXTERNAL PROFICIENCY SURVEY SAMPLES. THE ISSUE HAS BEEN ONGOING FOR APPROXIMATELY 2 MONTHS. RESULTS FOR 4 EXTERNAL PROFICIENCY SURVEY SAMPLES WERE PROVIDED, 1 SURVEY SAMPLE GAVE DISCREPANT RESULTS. INITIAL SURVEY RESULT GAVE 10.4; REPEAT GAVE 5.7 MG/DL. SURVEY SAMPLE REPEATED ON OTHER C501 (B) (4) AT THE SITE GIVING 5.9 MG/DL. RESULTS FOR THIS SURVEY SAMPLE WERE NOT REPORTED. NO PATIENT SAMPLES WERE INVOLVED. PHOSPHORUS REAGENT LOT NUMBER - 61972501. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. A SPECIAL WASH WAS INSTALLED FOR PHOSPHORUS AND THE HIGH RESULTS HAVE BEEN ELIMINATED. IN ADDITION, THE FSR ADJUSTED GEAR PUMP PRESSURE AND RINSE MECHANISM. TO VERIFY ANALYZER PERFORMANCE A PRECISION CHECK AND CONTROLS WERE RAN WITH ALL RESULTS ACCEPTABLE.

Additional Manufacturer Narrative

IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT THE BED EXIT WOULD NOT FUNCTION.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE EVENT DETERMINED THE ISSUE WAS RESOLVED AFTER INTRODUCING A WASH CYCLE BETWEEN THE LACTATE AND PHOSPHORUS ASSAYS BY THE FIELD SERVICE REPRESENTATIVE. FURTHER WASH CYCLES OUTSIDE OF THE PUBLISHED CARRY-OVER EVASION LIST MAY BE NECESSARY FOR SOME LABORATORIES. THIS IS DEPENDENT UPON INDEPENDENT LOCAL LABORATORY FACTORS, SUCH AS TEST MENU, THROUGHPUT, MAINTENANCE STATE, AND RUN TIME.