N
Patient 1
THE CUSTOMER REPORTED THAT THE PATIENT WAS MONITORED FOR KAPPA AND LAMBDA FOR SOME TIME USING ELECTROPHORESIS AND THE ALTERNATE NON-SIEMENS METHOD; THIS WAS UNKNOWN BY THE CUSTOMER WHEN THEY REPORTED THE FLC KAPPA AND FLC LAMBDA RESULTS USING SIEMENS N LATEX FLC LAMBDA AND N LATEX FLC KAPPA REAGENTS. THE CUSTOMER ALSO INDICATED THAT THEY RECENTLY STARTED USING SIEMENS REAGENTS FOR DETERMINATION OF FLC LAMBDA AND FLC KAPPA AND THAT THE AFFECTED SPECIMEN IS NOT AVAILABLE FOR FURTHER INVESTIGATION. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE DATA FILES ON THE BN PROSPEC SYSTEM TO DETERMINE THE CAUSE OF THE EVENT AND FOUND NO ISSUE. THE HSC SPECIALIST DETERMINED THAT THE SAVE DATA FILES CONTAINED TWO QUALITY CONTROL (QC) MEASUREMENTS AND THESE RESULTS WERE WITHIN EXPECTED RANGES. THE HSC SPECIALIST ALSO REVIEWED THE KINETICS OF THE AFFECTED MEASUREMENT ON 21-FEB-2018 AND QC AND DID NOT IDENTIFY ANY ISSUE. THE KINETICS OF THE SAMPLE MEASUREMENT USING THE NON-SIEMENS METHOD, WHICH IS NOT VALIDATED FOR USE ON THE BN PROSPEC SYSTEM, WERE NOT IN THE DATA FILES PROVIDED BY THE CUSTOMER. THE HSC SPECIALIST CONCLUDED THAT THERE WAS NO INDICATION OF A REAGENT OR SYSTEM MALFUNCTION. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THESE DEVICES IS REQUIRED. MDR 9610806-2018-00035, MDR 9610806-2018-00037, AND MDR 9610806-2018-00038 WERE FILED FOR THE SAME EVENT.