OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT

Description of Event or Problem

THIS EVENT DID NOT OCCUR IN THE USA. THIS EVENT OCCURRED IN AUSTRALIA ON A DEVICE THAT IS SIMILAR TO A DEVICE THAT IS MARKETED IN THE USA. A CUSTOMER CONTACTED THE BINDING SITE (TBS) AUSTRALIA ON THE 9TH OF JANUARY 2025, REGARDING A HIGH KAPPA RESULT OF 11,187.84 MG/L, OBTAINED FOR A PATIENT ON THE (B)(6) 2024. A SUBSEQUENT SAMPLE WAS REQUESTED, WHICH SHOWED A SIGNIFICANTLY LOWER KAPPA RESULT OF 211.32 MG/L ON THE (B)(6) 2024. THE ORIGINAL SAMPLE WAS RE-RUN ON (B)(6) 2024, AND RETURNED A KAPPA LEVEL OF 203.39 MG/L. THIS RESULT WAS MORE CONSISTENT WITH THE IGG KAPPA PARAPROTEIN RESULT (2 BANDS OF 7 G/L AND 2 G/L). FOLLOWING THE CONFIRMATION OF THE REPEAT RESULT, NO INCORRECT TREATMENT PLAN WAS GIVEN TO THE PATIENT. ALTHOUGH NO HARM HAS BEEN REPORTED, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF A CAUTION AS IF THE ERROR WERE TO RECUR ON THE FREE LIGHT CHAIN (FLC) KAPPA ASSAY AND RESULTS WERE USED IN ISOLATION, THERE IS A POSSIBILITY OF IT LEADING TO SERIOUS INJURY (INCORRECT PATIENT MANAGEMENT). AS STATED IN THE INSTRUCTIONS FOR USE OF THE FREE LIGHT CHAIN (FLC) KAPPA ASSAY, "THE RESULTS OF THIS ASSAY SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATIONS, AND OTHER FINDINGS INCLUDING PREVIOUS FREELITE RESULTS IF AVAILABLE" AND "DIAGNOSIS CANNOT BE MADE, AND TREATMENT MUST NOT BE GIVEN ON THE BASIS OF KAPPA FREE LIGHT CHAIN MEASUREMENTS ALONE. CLINICAL HISTORY AND OTHER LABORATORY FINDINGS MUST BE TAKEN INTO ACCOUNT.". PLEASE NOTE, THIS INCIDENT OCCURRED ON LK016.10.OPT LOT: 547064 WHICH IS NOT REGISTERED OR SOLD IN THE USA. WE ARE REPORTING BECAUSE OF THE SIMILAR DEVICES FOR USE ON THE OPTILITE ANALYSER, WHICH ARE REGISTERED AND SOLD IN THE USA ; LK016.OPT.A, LK016.10.OPT.A AND LK016.M.OPT.A.

Additional Manufacturer Narrative

THE PRODUCT IS PERFORMING TO SPECIFICATION AND IS ACCEPTABLE. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS OR FIELD SAFETY CORRECTIVE ACTIONS WERE DEEMED NECESSARY BY TBS.