MAUDE Adverse Event Report: THE BINDING SITE LIMITED OPTILITE® FREELITE® KAPPA FREE KIT

Model Number	LK016.OPT.A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported to the binding site an erroneously low kappa free light chain (flc) result (28.3 mg/l; ref range: 3.30 - 19.40 mg/l) obtained using the optilite® freelite® kappa free kit (product code: lk016.Opt.A), on (b)(6) 2025.The result was inconsistent with earlier results (839.6 & 789 mg/l) from sample dated (b)(6) 2025 (confirmed by error report analysis) and a stronger monoclonal protein band by serum electrophoresis.Lambda flc levels were consistently low and the kappa/ lambda ratio was abnormal throughout.There was no allegation of serious injury, although treatment was temporarily paused while the discrepancy was investigated.Quality controls (qc) were within range and acceptable throughout testing.A subsequent sample from the (b)(6) showed an increase in kappa flc levels (6426 mg/l).Although there have been no reports of serious harm or inappropriate therapy, the decision was taken to report as a matter of caution.If the error was to recur there is a possibility of serious injury if sample results were considered in isolation.As per the ifu, ins016.Opt.A, results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

• Brand Name: OPTILITE® FREELITE® KAPPA FREE KIT
• Common Device Name: OPTILITE® FREELITE® KAPPA FREE KIT
• Manufacturer (Section D): THE BINDING SITE LIMITED; 8 calthorpe road; edgbaston; birmingham, west midlands B15, 1QT; UK B15, 1QT
• MDR Report Key: 23596224
• Report Number: 2083566-2025-00003
• Device Sequence Number: 21411096
• Product Code: DFH
• UDI-Device Identifier: 05051700017794
• UDI-Public: 05051700017794
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025
• Report Date (Section F): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: LK016.OPT.A
• Device Catalogue Number: LK016.OPT.A
• Device Lot Number: 547348-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/19/2025