MAUDE Adverse Event Report: THE BINDING SITE LIMITED OPTILITE ANALYSER

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	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer contacted the binding site (pdx) on (b)(6) 2024 to report that erroneous results (no values provided) on multiple assays running on the binding site optilite analyser had been released from the laboratory to the clinician on the (b)(6) 2024.The clinician identified that certain sample results for freelite kappa free kit (lk016.Opt.A) and freelite lambda free kit (lk018.Opt.A) were not in line with patient clinical history.The customer reported that cleaning wipe material was wrapped around the mixing paddle of the optilite analyser.The material was removed, samples were re-run and all results were corrected within the same day ((b)(6) 2024).On the (b)(6) 2024 (manufacturer date of awareness), the customer provided values on affected samples from the 17th of april.A total of 179 results have been affected by this issue across nine different pdx assays.The assays impacted were freelite kappa free kit (lk016.Opt.A), freelite lambda free kit (lk018.Opt.A), beta-2-microglobulin (lk043.Opt.A), optilite® c3c kit (nk023.Opt.A), optilite® c4 kit (nk025.Opt.A), optilite® haptoglobin kit (nk058.Opt.A), optilite® iga kit (nk010.Opt.A), optilite® igm kit (nk012.Opt.A), optilite® igg kit (nk004.Opt.A).The customer confirmed that no reports have been received of harm to patients, change in patient management or inappropriate therapy due to the issue and all results were corrected on the day.The decision was taken to report as a matter of a caution as in one case on the free light chain (flc) kappa assay, if the error were to recur and results were used in isolation, there is a remote possibility of it leading to serious injury.For this sample, the initial result for the free light chain (flc) kappa falsely reported 174.51 mg/l.This result was above the total allowable error (tea) of 40% of the free light chain (flc) kappa assay.Upon rerun, the more accurate result of 43.73 mg/l (reference range: 3.30 - 19.40 mg/l) was obtained.If the initial result was used in isolation and the involved/uninvolved flc ratio is equal to or greater than 100, it could lead to a false diagnosis of myeloma and subsequent treatment.As per the instructions for use of the free light chain (flc) kappa assay (ins016.Opt.A) "diagnosis cannot be made, and treatment must not be given on the basis of kappa free light-chain and/ or lambda free light-chain measurements alone.Clinical history and other laboratory findings must be considered".

• Brand Name: OPTILITE ANALYSER
• Common Device Name: OPTILITE ANALYSER
• Manufacturer (Section D): THE BINDING SITE LIMITED; 8 calthorpe road; edgbaston; birmingham, b15 1qt ; UK
• MDR Report Key: 19342333
• Report Number: 2083566-2024-00003
• Device Sequence Number: 12933528
• Product Code: JJE
• UDI-Device Identifier: 05051700020893
• UDI-Public: 05051700020893
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/17/2024
• Report Date (Section F): 05/17/2024

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 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: 04/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• 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: 05/17/2024