DIMENSION®

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED DISCORDANT, FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULTS WERE OBTAINED ON THE DIMENSION EXL SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL INSTRUMENT. THE INITIAL RESULTS WERE QUESTIONED BY THE LABORATORY AND NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION INSTRUMENT AND AN ELEVATED RESULT WAS OBTAINED. THE SAME SAMPLE WAS ALSO PROCESSED WITH TWO NON-SIEMENS ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE WAS NO KNOWN IMPACT ON PATIENT TREATMENT OR CARE AND NO ALLEGED PATIENT HARM DUE TO THE DISCORDANT ELEVATED TAC RESULTS.

Additional Manufacturer Narrative

ORIGINAL MDR 2517506-2018-00402 WAS FILED 03-JUL-2018. ADDITIONAL INFORMATION (09-OCT-2018): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS COMPLETED THEIR INVESTIGATION OF THE EVENT. HSC HAS REVIEWED THE INFORMATION PROVIDED AND CANNOT DETERMINE CAUSE FOR THE DISCREPANT PATIENT RESULTS. THE CUSTOMER PROVIDED INFORMATION ON THE PATIENT MEDICATIONS: CELLCEPT, OMACOR, FEBUXOSTAT, PRASTAN AND BARACLUDE. THEY ALSO PROVIDED A PATIENT RESULT FROM ANOTHER DATE. A TAC TEST RESULT ON (B)(6) 2018 WAS 26.8 NG/ML. HSC REVIEW OF INSTRUMENT DATA DID NOT INDICATE ANY PRODUCT NONCONFORMANCE. QC PERFORMED DURING THE DAY OF PATIENT SAMPLE TESTING WAS WITHIN ACCEPTABLE LIMITS. REVIEW OF THE FILTER DATA FILE SHOWS THE AUTO RE-RUN FUNCTION OF THE TACROLIMUS (TAC) METHOD RECOVERED "ABNORMAL REACTION." A REVIEW OF PATIENT MEDICATIONS PROVIDED TO HSC INDICATED NO ADVERSE EFFECTS ON TACROLIMUS RESULTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DEVICE IS WORKING AS SPECIFIED. NO PRODUCT NONCONFORMANCE WAS IDENTIFIED. SECTION HAS BEEN UPDATED TO REFLECT THE HSC CONCLUSION.