BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILITE® FREELITE® LAMBDA FREE KIT

    MDR report key: 23232148 · Received October 7, 2025

    Report

    Report Number
    9614373-2025-00002
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 7, 2025
    Manufacturer
    THE BINDING SITE LIMITED
    Product Code
    DEH
    PMA / PMN Number
    K231290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE FAILURE HAS NOT YET BEEN DETERMINED, AND INVESTIGATIONS ARE ONGOING. THERE IS CURRENTLY NO INDICATION OF AN ISSUE WITH THE ASSAY LOT (PRODUCT CODE: LK018.OPT.A, KIT LOT: 529050) AND THERE HAVE BEEN TWO SIMILAR COMPLAINTS RAISED ON THIS ASSAY LOT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO THE BINDING SITE INC ON 09/SEP/2025 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 (B)(6) 2025. THUS, QUESTIONING THE RESULTS ON (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747325 OPTILITE® FREELITE® LAMBDA FREE KIT OPTILITE® FREELITE® LAMBDA FREE KIT DEH THE BINDING SITE LIMITED LK018.OPT.A 529050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other