DIMENSION®

Additional Manufacturer Narrative

ORIGINAL MDR WAS FILED ON (B)(6) 2018. ADDITIONAL INFORMATION (12-NOV-2018): THE CUSTOMER PROVIDED THE REQUESTED INFORMATION ON THE PATIENT MEDICATIONS AT THE TIME OF TESTING. TRAMADOLO 100MG. METOCLOPRAMIDE 10MG. METRONIDAZOL O 0,5G. CEFAZOLINA 1G. PARACETAMOLO 1G/100ML. ADV AGRAF( CAPSULE RIGIDE) 1MG. FLUCONAZOLO KABI 100MG. DEURSIL 300MG. CIPROXIN 500MG. LEVOFLOXACINA 500MG. LANSOPRAZOLO 30MG. LAM IVUDINA 100MG. DEURSIL 300MG. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS REVIEWED THE INFORMATION PROVIDED AND CONCLUDED THE INVESTIGATION. REVIEW OF THE INSTRUMENT FILTER DATA LOG DID NOT INDICATE ANY ISSUE WITH THE INSTRUMENT DURING THE TIME OF TESTING. A LIST OF MEDICATIONS THE PATIENT IN QUESTION WAS TAKING DURING THE TIME OF TESTING WAS PROVIDED. THIS LIST OF MEDICATIONS INCLUDED METOCLOPRAMIDE, WHICH IS LISTED IN THE TACROLIMUS TAC INSTRUCTIONS FOR USE (IFU) AS A DRUG THAT MAY INCREASE TACROLIMUS LEVELS. THE POTENTIAL CAUSE OF THE FALSELY ELEVATED RESULT MAY BE ATTRIBUTED TO THE PATIENT'S MEDICATION. NO PRODUCT NONCONFORMANCE WAS IDENTIFIED. THE SYSTEM IS WORKING AS SPECIFIED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION CONCLUSION. SECTIONS D1, D2, D3 AND D4 FOR THE SUSPECT MEDICAL DEVICE INFORMATION WERE CHANGED FROM THE DIMENSION EXL INSTRUMENT TO THE DIMENSION TAC FLEX REAGENT CARTRIDGE. SECTIONS G1, G2, AND G5 WERE UPDATED TO CHANGE THE MANUFACTURER INFORMATION FROM THE DIMENSION EXL INSTRUMENT TO THE DIMENSION TAC FLEX REAGENT CARTRIDGE. SECTION H4 WAS CHANGED TO THE TAC FLEX REAGENT CARTRIDGE LOT GB9134 MANUFACTURE DATE.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) ABOUT A DISCORDANT ELEVATED TACROLIMUS PATIENT RESULT ON THE DIMENSION EXL INSTRUMENT. A SIEMENS CUSTOMER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE FSE REPLACED THE SAMPLE DRAIN AND PERFORMED MAINTENANCE ON THE INSTRUMENT. SIEMENS HEADQUARTERS SUPPORT CENTER HAS REQUESTED ADDITIONAL INSTRUMENT DATA LOG DATA TO COMPLETE THE INVESTIGATION OF THE EVENT.

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 WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS PROCESSED BY AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TAC RESULT.