ELECSYS TACROLIMUS

Additional Manufacturer Narrative

THE REAGENT LOT NUMBER IS 688746. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TACROLIMUS ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THEY HAVE AN ONGOING ISSUE WITH THE TACROLIMUS ASSAY. THEY ARE RUNNING THE PATIENT SAMPLES ON BOTH OF THEIR E 411 ANALYZERS. PLEASE REFER TO THE ATTACHMENT PT-83173 IN THE MEDWATCH FOR THE TABLE CONTAINING EXAMPLES OF QUESTIONABLE RESULTS AND THE RESULTS REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

MEDWATCH FIELDS D DEVICE IDENTIFICATION D1-D4 UPDATED. THE INVESTIGATION REVIEWED THE DATA OF THE LAST CALIBRATION PERFORMED ON 22-JUN-2023; THE SIGNALS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE ALARM TRACE; NO ISSUES WERE NOTED. THE FIELD APPLICATION SPECIALIST (FAS) OBSERVED THE CUSTOMER'S STAFF TECHNOLOGISTS PRETREATING SAMPLE PROCEDURES; THERE WERE NO ISSUES NOTED. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND DETERMINED THAT THE EVENT WAS CAUSED BY EXTERNAL FACTORS AFFECTING MULTIPLE INSTRUMENTS. THE CUSTOMER PERFORMED A PATIENT CORRELATION STUDY BETWEEN THEIR ANALYZERS WITH SUCCESSFUL RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.