ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE PRE-ANALYTICAL INFORMATION THAT WAS PROVIDED SHOWED THAT NO RUBE RACK ADAPTERS WERE USED, WHICH ARE MANDATORY FOR 13 MM TUBES TO PREVENT QUESTIONABLE RESULTS. THE CUSTOMERS REPORTED THE CLOTTING TIME WAS 20-30 MINUTES, WHICH MAY BE LOW COMPARED TO MOST MANUFACTURERS' RECOMMENDATIONS OF AT LEAST 30 MINUTES. THE CENTRIFUGATION TIME AND FORCE MAY POTENTIALLY BE HIGH. IT WAS OBSERVED THAT THERE WAS A SIGNIFICANT AMOUNT OF TIME BETWEEN THE MEASUREMENTS ON THE FIRST DEVICE AND THE SECOND DEVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. THE INFORMATION PROVIDED INDICATES THAT THE COMPARISON BETWEEN THE TWO ANALYZERS IS SUBOPTIMAL. PRE-ANALYTICAL HANDLING ISSUES, AS WELL AS SAMPLE HANDLING IN BETWEEN THE MEASUREMENTS, CANNOT BE EXCLUDED AS THE ROOT CAUSE.

Additional Manufacturer Narrative

THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS VITAMIN B12 II RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM) FOR FIVE PATIENTS. PATIENT 1'S INITIAL RESULT WAS 80 PG/ML, AND THE REPEAT RESULT WAS 95.07 PG/ML. THE SAMPLE WAS REPEATED ON ANOTHER E 411 ANALYZER AND HAD A RESULT OF APPROXIMATELY 206.4 PG/ML. PATIENT 2'S INITIAL RESULT WAS 94.95 PG/ML, AND THE REPEAT RESULT ON ANOTHER E 411 ANALYZER WAS 192.6 PG/ML. PATIENT 3'S INITIAL RESULT WAS 92.45 PG/ML, AND THE REPEAT RESULT ON ANOTHER E 411 ANALYZER WAS 216.7 PG/ML. PATIENT 4'S INITIAL RESULT WAS 110.2 PG/ML, AND THE REPEAT RESULT ON ANOTHER E 411 ANALYZER WAS 227.8 PG/ML. PATIENT 5'S INITIAL RESULT WAS 75 PG/ML, AND THE REPEAT RESULT ON ANOTHER E 411 ANALYZER WAS 193.5 PG/ML. PATIENT 6'S INITIAL RESULT WAS 161.8 PG/ML, AND THE REPEAT RESULT ON ANOTHER E 411 ANALYZER WAS 270.1 PG/ML. THE CUSTOMER FOUND THE LOW RESULTS QUESTIONABLE AND REPEATED THE TEST ON THE OTHER ANALYZER.