Description of Event or Problem · 0
A CUSTOMER REPORTED TO THE BINDING SITE INC ON 09/SEP/25 TO REPORT MULTIPLE ABNORMALLY HIGH RESULTS OCCURRING FOR THE OPTILITE®. FREELITE® LAMBDA FREE KIT (PRODUCT CODE: LK018.OPT.A, LOT: 529050). THE CUSTOMER REPORTED THE ISSUE INITIALLY OCCURRED ON OPTILITE (SN (B)(6)) ON (B)(6) 2025 AND THE CUSTOMER BELIEVED 20 PATIENTS SAMPLES HAD BEEN AFFECTED. THIS WAS BASED ON QC FAILING TO VALIDATE THE CURVE ON (B)(6) 2025 AND AS WELL AS ON THE (B)(6) 2025. THUS QUESTIONING THE RESULTS ON THE (B)(6) 2025 WHEN NO ISSUES WERE REPORTED. FOLLOWING THE TWO QC FAILURES, FRESH QC REAGENT WAS USED, HOWEVER STILL FAILED, AND THE CUSTOMER RECALIBRATED AND THE QCS MET TARGET. CUSTOMER CONFIRMED THAT THE INCORRECT SAMPLE RESULTS WERE RELEASED FROM THE LAB TO THE PHYSICIAN WHICH WERE SUBSEQUENTLY CORRECTED. THE RELEASE OF THE ERRONEOUS RESULTS DID NOT LEAD TO ANY KNOWN OCCURRENCE OF PATIENT HARM. MANUFACTURER INVESTIGATIONS ON PROVIDED ERROR REPORTS INDICATED THAT 65 SAMPLES WERE LIKELY AFFECTED. ALTHOUGH THERE HAVE BEEN NO REPORTS OF PATIENT HARM, A CHANGE IN PATIENT MANAGEMENT, OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WAS TO RECUR, WITH RESPECT TO 2/65 RESULTS, THERE IS A REMOTE POSSIBILITY OF LEADING TO SERIOUS INJURY TO THE PATIENT. THE SPECIFIC SAMPLES WERE: SAMPLE 1 - INITIAL SERUM FREE LIGHT CHAIN (SFLC) LAMBDA RESULT = 1214MG/L, REPEATED LAMBDA RESULT - 782MG/L. SAMPLE 2 - INITIAL SFLC LAMBDA RESULT - 652MG/L, REPEATED LAMBDA RESULT - 454MG/L.. AS PER THE IFU, INS018.OPT.A, RESULTS OF THE FREE LIGHT CHAIN MEASUREMENTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS.