DIMENSION® TACROLIMUS FLEX® REAGENT CARTRIDGE

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HAS DETERMINED THAT THE CAUSE OF THE ERRONEOUSLY LOW TAC RESULT WAS USE ERROR. THE FOLLOWING ARE TEST STEPS IN THE TAC INSTRUCTIONS FOR USE UNDER PATIENT SAMPLES: - TRANSFER 200 UL TO A SAMPLE CUP OR SSC (SMALL SAMPLE CONTAINER) FOR PROCESSING ON THE INSTRUMENT - SELECT MODE: LIMITED CUP, NO LEVEL SENSE OF SSC AS APPROPRIATE - SELECT FLUID TYPE: CSF/BLOOD. IN ADDITION, THE IFU STATES: DO NOT PROCESS PRIMARY TUBES DIRECTLY ON THE DIMENSION FOR THIS ASSAY. THE CUSTOMER NEGLECTED TO POUR THE SAMPLE INTO A SAMPLE CUP OR SMALL SAMPLE CONTAINER THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER PROCESSED AN INFANT PATIENT SAMPLE ON THE DIMENSION XPAND SYSTEM FOR THE TACROLIMUS (TAC) METHOD USING AN EDTA WHOLE BLOOD COLLECTION TUBE INSTEAD OF USING A SAMPLE CUP OR SMALL SAMPLE CONTAINER (SSC) AS DESCRIBED IN THE TAC INSTRUCTIONS FOR USE. A RESULT LESS THAN THE ANALYTICAL MEASUREMENT RANGE (< 1 NG/ML) WAS OBTAINED AND REPORTED. THE PHYSICIAN INCREASED THE DOSE OF TACROLIMUS FOR THE INFANT PATIENT BASED ON THE FALSELY LOW TACROLIMUS RESULTS ON (B)(6) 2017. IT WAS STATED THAT ANOTHER CLINICAL LAB OPERATOR NOTICED THE ORIGINAL OPERATOR NEGLECTED TO USE SSC CUPS. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT USING A SSC AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU) FOR THE METHOD. A HIGHER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED ON (B)(6) 2017. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIALLY LOW TAC RESULT OR THE INCREASED DOSE OF TACROLIMUS. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 6, 2017 AND IT WAS STATED THAT THERE WAS NO BAD INFLUENCE ON THE PATIENT'S HEALTH.