BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7708791 · Received July 21, 2018

    Report

    Report Number
    8031673-2018-00631
    Event Type
    Malfunction
    Date Received
    July 21, 2018
    Date of Event
    June 21, 2018
    Report Date
    July 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR LHII ANALYTE. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE LH II ANALYTE APPLICATION MANUAL, STATES THE FOLLOWING: QUALITY CONTROL PROCEDURE. ASSAY QUALITY CONTROL SPECIMENS AS INSTRUCTED IN THE SPECIFIC OPERATOR'S MANUAL FOR THE ANALYZER. IN ADDITION, REFER TO THE AIA SYSTEM OPERATOR'S MANUAL FOR DETAILED INSTRUCTIONS ON DEFINING AND EDITING THE FILES. QUALITY CONTROL MATERIAL TO BE RUN WITH THIS ASSAY IS DEFINED BY INDIVIDUAL LABORATORY POLICY. EVALUATION OF RESULTS: QUALITY CONTROL. IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: AFTER CALIBRATION, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. THE THREE LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO CUSTOMER RAN SURVEY SAMPLE WHEN THE CONTROLS WERE OUT OF RANGE; THE CUSTOMER IS NOT A TRAINED LAB TECH.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT TWO (2) OF THREE (3) (B)(6) SAMPLES FOR LUTEINIZING HORMONE (LHII) WERE OUT OF RANGE HIGH ON THE AIA-360 INSTRUMENT. AT THE TIME THE CUSTOMER RAN THE SURVEY, THE LEVEL I AND III CONTROLS PASSED BUT LEVEL II WAS HIGH = 28.3; QC RANGE (13.1 - 24.3). TECHNICAL SUPPORT SPECIALIST INFORMED CUSTOMER THAT PATIENT AND ANY SURVEY SAMPLES SHOULD NOT BE REPORTED WHEN QC IS OUT OF RANGE, HENCE QC ISSUES MUST BE RESOLVED PRIOR TO REPORTING PATIENT RESULTS. (B)(6). TOSOH PARTICIPATED IN THIS SURVEY AND PASSED AND THE CUSTOMER FAILED DUE TO AN OPERATOR ERROR. THE CUSTOMER REPEATED THE THREE LEVELS OF QUALITY CONTROLS (QC) AND RESULTS ARE ALL IN ACCEPTABLE RANGES. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551044 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1