DIMENSION®

Additional Manufacturer Narrative

MDRS 2517506-2018-00423, 2517506-2018-00424, 2517506-2018-00425, 2517506-2018-00426, WERE FILED FOR THE SAME EVENT. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED A DISCORDANT, FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULT WAS OBTAINED ON THE DIMENSION EXL SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL INSTRUMENT. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE WAS NO KNOWN IMPACT ON PATIENT TREATMENT OR CARE AND NO ALLEGED PATIENT HARM DUE TO THE DISCORDANT ELEVATED TAC RESULT.

Additional Manufacturer Narrative

MDRS 2517506-2018-00423, 2517506-2018-00424, 2517506-2018-00425, 2517506-2018-00426, WERE FILED ON 23-JUL-2018 FOR THE SAME CUSTOMER INQUIRY. MDRS, 2517506-2018-00423, 2517506-2018-00424, 2517506-2018-00425, 2517506-2018-00426 SUPPLEMENT 1, WERE ALSO FILED ON 20-AUG-2018 FOR THE SAME CUSTOMER INQUIRY. ADDITIONAL INFORMATION (29-OCT-2018): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS COMPLETED THEIR EVALUATION OF THIS EVENT. THE CUSTOMER REPORTED HIGHER RESULTS FOR TACROLIMUS (TAC) USING REAGENT LOT GA9106 ON THE DIMENSION INSTRUMENT WHEN COMPARED TO LIQUID CHROMATOGRAPHY MASS SPECTROMETRY (LC-MS) TACROLIMUS RESULTS. SIEMENS REQUESTED A PATIENT SAMPLE FOR INTERNAL TESTING. THE ADDITIONAL TESTING COULD NOT BE PERFORMED BY THE SIEMENS TECHNICAL SERVICE LABORATORY (TSL) DUE TO THE POOR QUALITY OF THE SAMPLE SUBMITTED. THE CAUSE OF THE EVENT IS UNKNOWN. SIEMENS INVESTIGATION OF THE PROVIDED DATA SHOWED THAT THERE WERE NO PRODUCT NONCONFORMANCES OR PRODUCT ISSUES IDENTIFIED WITH THE DIMENSION INSTRUMENTS AT THIS SITE. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION CONCLUSION.

Additional Manufacturer Narrative

ORIGINAL MDRS: 2517506-2018-00423, 2517506-2018-00424, 2517506-2018-00425, 2517506-2018-00426 WERE FILED 23-JUL-2018. ADDITIONAL INFORMATION (27-JUL-2018): HEADQUARTERS SUPPORT CENTER (HSC) HAS REVIEWED THE INFORMATION PROVIDED. THE DATA IS CONSISTENT WITH THE TACROLIMUS (TAC) VALUES INCREASING OVER A THREE DAY PERIOD OF SAMPLE COLLECTION. THE LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY (LCMS) AND DIMENSION EXL RESULTS INCREASE IN CONCENTRATION OVER TIME. NO PEER QC OR SURVEY VALUES WERE PROVIDED. REVIEW OF THE DIMENSION EXL QUALITY CONTROL (QC) DATA FOR THE 3 DAYS OF TAC TESTING DID NOT INDICATE ANY ISSUES WITH PRECISION OR ACCURACY. RESULTS FOR ALL REPEATED SAMPLES DISPLAYED GOOD PRECISION. THERE WERE NO INSTRUMENT ISSUES FOUND IN THE FILTER DATA FILES. UPDATED TO REFLECT THE HSC INVESTIGATION. SIEMENS IS STILL INVESTIGATING THE EVENT.