BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILITE ANALYSER

    MDR report key: 18232151 · Received November 29, 2023

    Report

    Report Number
    2083566-2023-00003
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 29, 2023
    Manufacturer
    THE BINDING SITE LIMITED
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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 LGG, LGA AND LGM RESULTS OBTAINED ON THE OPTILITE ANALYSER ON THE 3OTH 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, THE BINDING SITE GROUP LIMITED AND THE BINDING SITE INC. ARE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136946 OPTILITE ANALYSER OPTILITE ANALYSER JJE THE BINDING SITE LIMITED IE700

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other