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

Model Number	LK016.OPT.A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue is due to either a sample specific issue or laboratory error.The binding site investigation determined that there is no indication of malfunction of the assay, and the optilite instrument is performing as expected.Therefore, no corrective and/or preventive actions or field safety corrective actions were deemed necessary.
Event or Problem Description
The customer released a discrepant, falsely elevated kappa free light chain (flc) result (1262.39 mg/l; ref range: 3.30-19.40 mg/l) obtained using the freelite® assay.The patient had a prior diagnosis of al amyloidosis and was under routine monitoring.The elevated result (taken (b)(6) 2026) was inconsistent with the patient's clinical history and follow up testing.A new sample, taken on (b)(6) 2026, gave a kappa result of 11.47 mg/l, consistent with historical patient results.The customer confirmed that patient treatment was not affected.The investigation determined that quality control were within range, and no analyser or assay malfunction was identified.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 were 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 1 QT; UK B15 1QT
• Manufacturer (Section G): THE BINDING SITE LIMITED; 8 calthorpe road; edgbaston; birmingham, west midlands B15 1 QT; UK B15 1QT
• Manufacturer Contact: richard hughes ; 8 calthorpe road; edgbaston; birmingham, west midlands B15 1-QT ; UK B15 1QT
• MDR Report Key: 24556210
• Report Number: 9614373-2026-00001
• Device Sequence Number: 8932688
• Product Code: DFH
• UDI-Device Identifier: 05051700017794
• UDI-Public: 05051700017794
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K231290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown