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	Malfunction
Additional Manufacturer Narrative
The exact root cause has not been fully established.Based on error report analysis by the binding site and provided information, a sample-specific issue is suspected.The reagent lot has no identified issues and the optilite instrument is performing as expected.Additionally, no similar complaints have been received for the lot.
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 22 october 2025.The result was inconsistent with earlier results (839.6 & 789 mg/l) from sample dated 17 october 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 10th november 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 1 QT; UK B15 1QT
• Manufacturer (Section G): THE BINDING SITE LIMITED; 8 calthorpe road; edgbaston; birmingham, 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: 23582756
• Report Number: 9614373-2025-00003
• Device Sequence Number: 18447249
• Product Code: DFH
• UDI-Device Identifier: 05051700017794
• UDI-Public: 05051700017794
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 11/18/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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