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	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No malfunction or performance issues of the optilite analyzer or the freelite kappa and lambda assays have been identified.Therefore, no corrective and/or preventive or field safety corrective action was deemed necessary.The issue is related to how the affected site's lis is configured by the local end user's it department or lis supplier to handle less than "<" results obtained on the freelite kappa and lambda assays on the optilite analyser.See the 'relevant tests/ laboratory data, including dates' section b6 above.As per ifu, section 8.6, "interpretation of results" if a sample gives a result that is considered implausible, the sample should be retested.For the affected sample results, the "<" results reported by the optilite analyser was manually accepted.This "<" result was then converted by the lis set up to a "<" result "below the test limit" for the respective kappa and lambda flc assays; <0.6mg/l for kappa free and <1.5mg/l for lambda free.
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 analyser 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 analyser 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® ANALYSER
• Manufacturer (Section D): THE BINDING SITE LIMITED; 8 calthorpe road,; edgbaston; birmingham, uk B15 1 QT; UK B15 1QT
• Manufacturer (Section G): THE BINDING SITE LIMITED; 8 calthorpe road,; edgbaston.; birmingham, uk B151Q T; UK B151QT
• Manufacturer Contact: richard hughes ; 8 calthorpe road,; edgbaston; birmingham, uk B15 1-QT ; UK B15 1QT
• MDR Report Key: 18266434
• Report Number: 9614373-2023-00002
• Device Sequence Number: 7672520
• Product Code: JJE
• UDI-Device Identifier: 05051700020893
• UDI-Public: 5051700020893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• 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): 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown