DIMENSION®

Additional Manufacturer Narrative

MDRS 2517506-2018-00591, 2517506-2018-00592, 2517506-2018-00593, 2517506-2018-00594, 2517506-2018-00595, 2517506-2018-00596, 2517506-2018-00597, AND 2517506-2018-00598 WERE ALSO FILED FOR THE SAME CUSTOMER INQUIRY. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) ABOUT A DISCORDANT ELEVATED TACROLIMUS PATIENT RESULT ON THE DIMENSION EXL INSTRUMENT. THE PHYSICIAN QUESTIONED THE RESULT AT A LATER DATE BASED UPON SUBSEQUENT PATIENT TACROLIMUS DOSAGE AND RESULTS. SIEMENS IS INVESTIGATING THE INCIDENT.

Description of Event or Problem

A DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TAC RESULT.

Additional Manufacturer Narrative

MDRS 2517506-2018-00591, 2517506-2018-00592, 2517506-2018-00593, 2517506-2018-00594, 2517506-2018-00595, 2517506-2018-00596, 2517506-2018-00597, AND 2517506-2018-00598 WERE ALSO FILED ON 26-OCT-2018 FOR THE SAME CUSTOMER INQUIRY. ADDITIONAL INFORMATION (31-OCT-2018): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS COMPLETED THEIR EVALUATION OF THIS EVENT. THE CUSTOMER OBTAINED A FALSELY ELEVATED RESULT ON A SINGLE PATIENT FOR TACROLIMUS (TAC) ON THE DIMENSION EXL. A LIST OF THE PATIENT'S MEDICATIONS WAS PROVIDED TO SIEMENS BY THE CUSTOMER AND THE MEDICATIONS FOR THIS PATIENT INCLUDED THE FOLLOWING; GLICLAZIDE, METFORMIN, MYCOPHENOLATE, ASPIRIN, CANDESARTAN, AMLODIPINE, TACROLIMUS, ALLOPURINOL AND OMEPRAZOLE. HSC HAS REVIEWED THE INFORMATION PROVIDED. THE PATIENT WAS TAKING OMEPRAZOLE, WHICH IS LISTED IN THE TAC INSTRUCTIONS FOR USE AS A DRUG THAT MAY INCREASE TACROLIMUS VALUES. THE CUSTOMER HAS NOT ESCALATED COMPLAINTS FOR ANY ADDITIONAL PATIENTS WITH CONSISTENTLY HIGH TAC VALUES. THIS ISSUE IS LIMITED TO THIS SINGLE PATIENT. REVIEW OF ADDITIONAL INSTRUMENT DATA PROVIDED BY THE CUSTOMER DID NOT SHOW ANY INDICATION OF AN INSTRUMENT ISSUE DURING THE TIME OF TESTING. THE CAUSE OF THE ELEVATED TAC RESULT MAY BE ATTRIBUTED TO THE MEDICATION OMEPRAZOLE THAT THE PATIENT WAS TAKING. NO PRODUCT NONCONFORMANCE WAS IDENTIFIED. THE DEVICE IS WORKING AS SPECIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. UPDATED TO REFLECT THE HSC INVESTIGATION CONCLUSION.