ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC WAS WITHIN RANGE BEFORE THE SAMPLE MEASUREMENT. NO RELEVANT ALARMS WERE PRESENT IN THE ANALYZER ALARM TRACE. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A SAMPLE MISMATCH WHILE USING THE COBAS PRO SSU ANALYZER. THE CUSTOMER MANUALLY PROGRAMMED A SAMPLE FOR SODIUM AND SERUM INDICES USING THE PATIENT'S NAME AS THE SAMPLE ID (B)(6). HOWEVER, WHEN THE SAMPLE WAS LOADED ON THE ANALYZER, IT POPULATED A DIFFERENT PATIENT NAME AND A VITAMIN B12 TEST WAS ADDED. WHEN THE RACK WAS LOADED, THE SYSTEM REGISTERED THE SAMPLE WITH A PREVIOUS PATIENT'S SAMPLE ID, (B)(6). THE RESULT FOR VITAMIN B12 WAS 1376 PG/ML. MULTIPLE OTHER PATIENT SAMPLES WERE MANUALLY PROGRAMMED, AND THOSE ALL RAN APPROPRIATELY. THE SUSPECT SAMPLE WAS THEN MANUALLY REPROGRAMMED IN THE SAME MANNER, EXCEPT IT WAS PROGRAMMED TO RUN IN A DIFFERENT POSITION ON THE SAME RACK (RACK S40012-4). THE SAMPLE THEN RAN CORRECTLY. THE RESULT FOR VITAMIN B12 WAS 325 PG/ML. NO RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE COBAS PRO SSU SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE AND WAS UNABLE TO REPRODUCE THE ISSUE. HE AND THE CUSTOMER MANUALLY PROGRAMMED SAMPLES WITHOUT ISSUES. THE CUSTOMER STATED THAT THERE WAS A POSSIBILITY THAT THE EVENT WAS DUE TO USER ERROR. THE INVESTIGATION IS ONGOING.