MAUDE Adverse Event Report: THE BINDING SITE LIMITED OPTILITE® ANALYSER; OPTILITE® ANALYZER

Model Number	IE700
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On the 7th of november 2023, while supporting a customer on a query regarding high activity "activity check (ac)" flags on the optilite analyzer when running freelite kappa free kit (lk016.Opt.A) and freelite lambda free kit (lk018.Opt.A), the customer identified six sample ids where a less than'<' flag had been manually accepted.The customer identified that each result had been altered and released by their lis software as low values of <0.6 mg/l free light chain (flc) kappa or <1.5mg/l flc lambda, where the actual result returned by the optilite analyzer was abnormally high (reference ranges stated in the product instructions for use: kappa free (3.30 -19.40 mg/l) and lambda free (5.71 - 26.30 mg/l)).The flc kappa/lambda ratios remained correctly abnormal albethey inverted in 5 of the 6 cases (kappa/lambda ratio normal ref.Range: 0.26 - 1.65mg/l).The customer confirmed that no reports of harm to patients, change in patient management or inappropriate therapy have been received.Although no harm has been reported to date and the analyser and assays are performing as intended, the decision was taken to report as a matter of caution as in three of the six cases, if the error were to recur, there is a remote possibility of it leading to serious injury.

• Brand Name: OPTILITE® ANALYSER
• Common Device Name: OPTILITE® ANALYZER
• Manufacturer (Section D): THE BINDING SITE LIMITED; 8 calthorpe road, edgbaston; birmingham, uk b15 1qt ; UK
• MDR Report Key: 18268595
• Report Number: 2083566-2023-00004
• Device Sequence Number: 3954246
• Product Code: JJE
• UDI-Device Identifier: 05051700020893
• UDI-Public: 5051700020893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/05/2023
• Report Date (Section F): 12/05/2023

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
• Device Model Number: IE700
• Device Catalogue Number: IE700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2023
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 12/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2023
• 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: 12/05/2023