IMMULITE 2000 XPI

Additional Manufacturer Narrative

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS NOT SENT TO THE CUSTOMER SITE AS THE CUSTOMER INDICATED THAT THEY COULD NOT RULE OUT THE PRESENCE OF AN AIR BUBBLE IN THE SAMPLE WHEN INITIALLY TESTED ON THE IMMULITE 2000 XPI. THE CUSTOMER CONTINUES TO RUN THE IMMULITE 2000 XPI, AND HAVE ADVISED ALL THEIR LABORATORY TECHNICIANS TO DOUBLE CHECK SAMPLE AND REAGENT FOR AIR BUBBLES PRIOR TO USE. THE CAUSE OF THE FALSELY LOW HOMOCYSTEINE RESULT ON THE ONE PATIENT SAMPLE IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

A DISCORDANT, FALSELY LOW HOMOCYSTEINE RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT RESULTING HIGHER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW HOMOCYSTEINE RESULT OBTAINED ON THE IMMULITE 2000 XPI.

Additional Manufacturer Narrative

INITIAL MDR 2247117-2016-00009 WAS FILED ON (B)(4) 2016. ADDITIONAL INFORMATION (4/27/2016): A SIEMENS FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE. THE FSE NOTICED THAT THE GROUNDING OF THE SAMPLE CAROUSEL WAS >20 OHM, SO THE CONNECTION OF THE GROUNDING BRUSH WAS ADJUSTED, LOWERING THE GROUNDING TO <1 OHM. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.