ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE ALARM TRACE SHOWED SEVERAL "SAMPLE SHORT", "PROCELL SHORT", AND "CLEANCELL SHORT" ALARMS. THE CALIBRATION RESULTS ARE ACCEPTABLE. THE QC SHOWS UNSTABLE PERFORMANCE WITH MULTIPLE HIGH OUT-OF-RANGE VALUES. THE FIELD SERVICE REPRESENTATIVE PERFORMED MAINTENANCE TASKS INCLUDING PRIMES, CLEANINGS, AND AIR PURGES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 100 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 100 PG/ML WITH A DATA FLAG. A 1:2 DILUTION WAS PERFORMED AND THE RESULT WAS 200 PG/ML WITH A DATA FLAG. A 1:10 DILUTION WAS PERFORMED AND THE RESULT WAS 1000 PG/ML WITH A DATA FLAG. ON (B)(6) 2024, THE REPEATED RESULT WAS 100 PG/ML WITH A DATA FLAG A 1:50 DILUTION WAS PERFORMED AND THE RESULT WAS 104 PG/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 2: ON (B)(6) 2024, THE INITIAL RESULT WAS 100 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH AN ONBOARD DILUTION (1:10) ON ANOTHER MODULE AND THE RESULT WAS >1476 PG/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. A MANUAL 1:5 DILUTION WAS PERFORMED AND THE RESULT WAS 500 PG/ML.

Additional Manufacturer Narrative

D4 EXPIRATION DATE WAS UPDATED. THE INVESTIGATION FOUND THAT THE ISSUE LIKELY OCCURRED BECAUSE OF SETTINGS ON THE INFINITY SOFTWARE, WHICH MAY HAVE LIMITED THE INFORMATION DISPLAYED. IT WAS CONFIRMED THAT THERE ARE THREE SETTINGS WHICH MAY IMPACT HOW RESULTS ARE DISPLAYED ON THE USER INTERFACE: RULE ENGINE, ALPHANUMERIC TRANSFORMATION, AND RESULT RANGE TRANSFORMATION. THE CUSTOMER'S DATA FILES WERE REQUESTED, BUT THE FILES WERE UNABLE TO BE OBTAINED FOR REVIEW. THE SOFTWARE PERFORMED WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.