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	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No corrective and/or preventive or field safety corrective actions were deemed necessary by tbs as no malfunction of the optilite analyser has been identified.The analyser is working to specification (confirmed by error report analysis) and from the investigations performed to date, the issue is attributed to incorrect lis requests.The date of installation of the optilite analyser at the affected customer site is (b)(6) 2021.The end users it department/lis supplier are responsible for configuring the lis according to the lis manual.The customer has indicated that the lis supplier is investigating the case, tbs will support where required.
Event or Problem Description
This event did not occur in the usa.We are submitting this report as the event occurred at a healthcare facility in the united kingdom on a device that is also marketed in the usa.A customer contacted tbs regarding discrepant igg, iga and igm results obtained on the optilite analyser on the 30th of october.The samples were repeated on the 1st of november 2023 where it was observed that the initial results were reporting around double the concentration seen on the repeat testing.Investigations concluded that no malfunction of the optilite analyser has been identified and discrepancy in the results were caused by incorrect laboratory information system (lis) request.The customer confirmed discrepant results were released from the laboratory with currently no reports of harm to patients, change in patient management or inappropriate therapy.Although no harm has been reported to date, tbs is reporting this as a matter of caution.If the malfunction of the lis software were to recur, it could possibly impact results on any optilite assay run on the optilite analyser, where it may cause or contribute to serious injury.The highest risk classification associated with any tbs optilite assay is class ii.

• 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: 18208586
• Report Number: 9614373-2023-00001
• Device Sequence Number: 20449231
• Product Code: JJE
• UDI-Device Identifier: 05051700020893
• UDI-Public: 5051700020893
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2023

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: 11/01/2023
• Initial Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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