MAUDE Adverse Event Report: THE BINDING SITE LIMITED OPTILITE ANALYSER

Model Number	IE700
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event did not occur in the usa.We are submitting this report because the event occurred at a healthcare facility in the united kingdom, involving a device that is also marketed in the usa.On 6th december 2024 (the manufacturer's date of awareness), a customer informed the binding site (tbs) that they observed results being reported as double what was expected.The dilution factor sent to the optilite was "1" instead of the expected "0" per the optilite lis (laboratory information system) manual (ins700.Lis).An initial review by the customer identified seven impacted samples dating back to (b)(6) 2024.Further investigations revealed that 146 test requests had been impacted since (b)(6) 2024.Investigations concluded that there was no malfunction of the optilite analyser involved in the incident.The analyser is working as expected.The issue is anticipated to be due to an incorrect lis/middleware request, where a dilution factor of "1" was added instead of "0" as recommended in the optilite lis manual.Although no harm has been reported to date, the incident is being reported as a precaution due to the potential for an erroneous two-fold increase in results caused by incorrect lis/middleware requests.The highest risk classification associated with any tbs optilite assay is class ii and the highest severity of harm that could be assigned to the associated potential hazard would be categorised as serious.Therefore, if this incident were to recur, it could possibly impact results on any optilite assay, potentially causing or contributing to serious injury.

• 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: 21068423
• Report Number: 2083566-2024-00004
• Device Sequence Number: 8408977
• Product Code: JJE
• UDI-Device Identifier: 05051700020893
• UDI-Public: 05051700020893
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/03/2024
• Report Date (Section F): 01/03/2025

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 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: 12/06/2024
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 01/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• 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: 01/03/2025