Description of Event or Problem · 1
ON (B)(6) 2012 DURING OPERATION, THERE WAS AN UNEXPLAINED POWER FAILURE FOR THE COBAS 8000 3 602 MODULE. THE POWER WAS RESTORED AND SPECIMEN TESTING CONTINUED. ON (B)(6) 2012, THE (B)(6) WAS QUESTIONED ABOUT CONSISTENTLY LOW CORTISOL RESULTS FROM A PT THAT WAS TESTED ON (B)(6) 2012. REVIEW OF INSTRUMENT QC AND MAINTENANCE RECORDS REVEALED NO CONCERN. REQUEST FOR FSR REVIEW OF ALARMS/SYSTEM ISSUES THAT MAY HAVE BEEN MISSED. NO SIGNIFICANT FINDINGS. SPECIMENS FROM THE QUESTIONABLE RESULTS WERE FORWARDED TO ANOTHER LABORATORY AND RESULTS WERE SIGNIFICANTLY HIGHER AND MORE IN LINE WITH THE EXPECTED RESULTS PER PT CLINICAL DIAGNOSIS. ROCHE WAS NOTIFIED OF THE FINDINGS AND THE LAB REQUESTED AN ESCALATION OF ISSUE TO ENSURE THAT THE CAUSE WAS IDENTIFIED SO THAT APPROPRIATE CORRECTIVE ACTIONS COULD BE IMPLEMENTED TO PREVENT ANY RE-OCCURRENCE OF "UNEXPLAINABLE ERRONEOUS" RESULTS. AN EXTENSIVE INVESTIGATION WAS INITIATED. THIS INCLUDED REVIEW OF THE ANALYZER MAINTENANCE RECORDS, REAGENTS, CALIBRATORS, CONTROLS, FSR SERVICE CHECKS AND ERROR LOG REVIEW. REVIEW OF ALL PT TEST RESULTS ON DATE DID INDICATE THAT THERE WERE OTHER IMMUNOASSAY E 602 MODULE TESTS RESULTS THAT WERE SUSPECT EITHER EXTREMELY LOW OR HIGH. ON MONDAY, (B)(4) 2012, ROCHE INFORMED (B)(6) THAT THEIR INVESTIGATION HAD CONCLUDED AND THE RESOLUTION WAS A SOFTWARE UPDATE. THE ERRONEOUS RESULTS WERE CAUSED BY THE POWER FAILURE IN THE PC AND THE CONTROL UNIT. WHEN THE UNIT WAS REBOOTED, THE BARCODE INFO FROM THE REAGENT PACKS WAS NOT READ APPROPRIATELY AND AN INCORRECT EVAL ALGORITHM WAS USED, CAUSING MISCALCULATION OF RESULTS. THIS ISSUE HAD BEEN IDENTIFIED (REFER TO ROCHE SOFTWARE BULLETIN 12-158 DATED 08/03/2012) AND SOFTWARE VERSION 03-03 PROVIDED THIS CORRECTIVE ACTION: "IN THE CASE OF A RECONNECTION FAILURE OF THE COBAS 3 602 MODULE, THE SYSTEM DOES NOT GO INTO OPERATION MODE, AND A 061-00000X UNEXPECTED REAGENT REGISTRATION ALARM IS GENERATED. THE OPERATOR SHOULD PERFORM REAGENT REGISTRATION PRIOR TO OPERATION."