Description of Event or Problem · 0
THIS EVENT DID NOT OCCUR IN THE USA. THIS EVENT OCCURRED IN THE UNITED KINGDOM ON A DEVICE (OPTILITE® FREELITE® KAPPA FREE KIT, MODEL #: LK016.OPT) THAT IS SIMILAR TO THE DEVICES (OPTILITE FREELITE KAPPA FREE KIT MODEL #: LK016.OPT.A (510(K) NUMBER: K231290), OPTILITE FREELITE KAPPA FREE KIT (X10) MODEL #: LK016.10.OPT.A (510(K) NUMBER: K231290) THAT ARE MARKETED IN THE USA. ON (B)(6) 2026, A CUSTOMER RELEASED A FALSELY ELEVATED KAPPA FREE LIGHT CHAIN (FLC) RESULT OF 102.66 MG/L (REFERENCE RANGE: 3.3-19.4 MG/L) OBTAINED USING THE OPTILITE® FREELITE® KAPPA FREE KIT (MODEL #: LK016.OPT). ON (B)(6) 2026, REPEAT BLOOD SAMPLES WERE COLLECTED FROM THE SAME PATIENT AND TESTED USING THE SAME KIT LOT, PRODUCING A RESULT OF 28.1 MG/L, WHICH INDICATED THE INITIAL RESULT WAS FALSELY ELEVATED. DUE TO THE FALSELY ELEVATED KAPPA FLC RESULT, THE PATIENT WAS REFERRED TO HAEMATOLOGY. POSSIBLE PLASMA CELL DISORDER WAS INVESTIGATED, INCLUDING A BONE MARROW BIOPSY AND PET-CT SCAN (INVASIVE PROCEDURES), WHICH ARE NOW DEEMED TO BE POTENTIALLY UNNECESSARY FOLLOWING THE REPEAT TESTING. THERE HAVE BEEN NO REPORTS OF DEATH AND NO INDICATION OF COMPLICATIONS FOLLOWING THE PROCEDURES: HOWEVER, THE CLINICIAN ASSESSED THAT THE PATIENT EXPERIENCED MODERATE HARM. TBS CONSIDERS AN UNNECESSARY BONE MARROW BIOPSY (AS AN INVASIVE PROCEDURE) TO BE A SERIOUS MEDICAL EVENT; HENCE, REPORTING THIS CASE. INVESTIGATIONS INDICATE THAT THE FALSELY ELEVATED RESULT MAY POTENTIALLY BE LINKED TO MAINTENANCE OF THE ANALYSER (OPTILITE ANALYSER, MODEL #: IE700) AT THE CUSTOMER SITE. NO ASSAY PERFORMANCE ISSUES HAVE BEEN IDENTIFIED.