COBAS 6000 C501 MODULE

Description of Event or Problem

CUSTOMER RECEIVED "FLIERS" BEGINNING 5/2/10 FOR MULTIPLE ASSAYS. THE FOLLOWING PATIENT RESULTS WERE PROVIDED BY CUSTOMER: PATIENT 1, INITIAL TOTAL PROTEIN RESULT 1.1 (ACCOMPANIED BY DATA FLAGS), REPEATED ON ANOTHER COBAS ANALYZER GAVE 6.5 G/DL. THE 6.5 G/DL TOTAL PROTEIN RESULT WAS REPORTED. PATIENT 2, FEMALE, (B) (6), TESTING (B) (6) 2010, INITIAL GLUCOSE RESULT 7 MG/DL (ACCOMPANIED BY DATA FLAGS), REPEATED THREE TIMES GAVE 87 (ANOTHER COBAS ANALYZER), 88 (BLOOD GAS ANALYZER), AND 86 MG/DL (ORIGINAL ANALYZER). THE 87 MG/DL GLUCOSE RESULT WAS REPORTED; INITIAL SODIUM RESULT 132 MMOL/L (ACCOMPANIED BY DATA FLAGS), REPEATED TWICE GAVE 135 (ANOTHER COBAS ANALYZER) AND 141 MMOL/L (BLOOD GAS ANALYZER, DIFFERENT METHODOLOGY). CUSTOMER STATED THE ABERRANT RESULTS WERE NOT SENT TO THE FLOOR, ONLY THE CORRECT RESULTS WERE REPORTED. REAGENT LOT #S: GLUCOSE 61943801 TOTAL PROTEIN 62112501 SODIUM ELECTRODE LOT NOT PROVIDED THE FIELD SERVICE REPRESENTATIVE FOUND A MISADJUSTED SAMPLE LINE CAUSED POOR SAMPLING AND HE ADJUSTED THE SAMPLE LINE. CUSTOMER RAN SAMPLES WITH NO FURTHER ISSUES.

Additional Manufacturer Narrative

IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.