BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7963041 · Received October 12, 2018

    Report

    Report Number
    8031673-2018-00908
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 12, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER'S SITE AND CONFIRMED CUSTOMER'S REPORTED EVENT. THE CUSTOMER HAD RECALIBRATED AND READINGS WERE NORMAL, BUT READINGS WENT OUT A DAY AFTER THE RECALIBRATION. FSE DECONTAMINATED THE ANALYZER FULLY WITH 20% BLEACH SOLUTION SUSPECTING A STUBBORN CONTAMINANT, AND LET THE SOLUTION SOAK INTO THE LINES FOR 15 MINUTES. FSE RAN QUALITY CONTROLS (QC) WITHOUT CALIBRATION AND THEY WERE VERY CLOSE TO THE MEAN ON ALL THREE LEVELS. FSE PERFORMED ANNUAL PM THE NEXT DAY, THEN CALIBRATED AND RAN FSH QCS. ALL FSH QCS WERE IN RANGE. FSE RETURNED ANALYZER TO CUSTOMER, BUT FOLLOWED UP WITH CUSTOMER THE FOLLOWING WEEK TO ESTABLISH LONG-TERM STABILITY. THE CUSTOMER CONFIRMED THAT ALL ANALYTES WERE WITHIN THEIR RESPECTIVE QC RANGES. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 ANALYZER IS FUNCTIONING AS EXPECTED. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE ST AIA-PACK FSH ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: CALIBRATION 2A) CALIBRATION CURVE THE CALIBRATORS FOR USE WITH THE ST AIA-PACK FSH HAVE BEEN STANDARDIZED AGAINST WHO 2ND IRP 78/549 (1980). THE CALIBRATION CURVE FOR THE ST AIA-PACK FSH HAS BEEN SHOWN TO BE STABLE FOR UP TO 90 DAYS. CALIBRATION STABILITY IS MONITORED BY QUALITY CONTROL PERFORMANCE AND IS DEPENDENT UPON PROPER REAGENT HANDLING AND AIA SYSTEM MAINTENANCE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. RECALIBRATION MAY BE NECESSARY MORE FREQUENTLY IF CONTROLS ARE OUT OF THE ESTABLISHED RANGE FOR THIS ASSAY OR IF CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, OR DETECTOR LAMP ADJUSTMENT OR CHANGE). FOR FURTHER INFORMATION REGARDING INSTRUMENT OPERATION, CONSULT THE AIA SYSTEM OPERATOR'S MANUAL. 2B) CALIBRATION PROCEDURE I) REFER TO THE APPROPRIATE AIA SYSTEM OPERATOR'S MANUAL FOR PROCEDURAL INSTRUCTIONS. II) VERIFY THAT THE CALIBRATOR CONCENTRATIONS LISTED ON THE VIAL LABELS AS WELL AS THE CALIBRATOR LOT NUMBERS HAVE BEEN CORRECTLY ENTERED INTO THE SOFTWARE. III) CALIBRATORS FOR ST AIA-PACK FSH ARE IN LIQUID FORM AND NEED NO RECONSTITUTION. TOSOH RECOMMENDS THAT ALL CALIBRATORS BE RUN IN TRIPLICATE. 2C) CALIBRATION ACCEPTABILITY CRITERIA I) THE MEAN RATE FOR THE ZERO CALIBRATOR SHOULD BE < 3.0 NM/SEC. II) SINCE THERE IS A DIRECT RELATIONSHIP BETWEEN CONCENTRATION AND RATE, THE RATES SHOULD INCREASE AS THE CONCENTRATION INCREASES. III) THE REPLICATE VALUES SHOULD BE WITHIN A 10% RANGE. 2D) CALIBRATION REVIEW AND ACCEPTANCE I) USING THE CRITERIA ABOVE, REVIEW THE CALIBRATION CURVE CAREFULLY. II) EDIT THE CALIBRATION IF NECESSARY, THEN ACCEPT THE CALIBRATION. III) FOR FURTHER INFORMATION REGARDING CALIBRATION, CONSULT THE SPECIFIC AIA SYSTEM OPERATOR'S MANUAL. 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 LIKELY CAUSE OF THE REPORTED EVENT WAS DUE TO BIOLOGICAL CONTAMINATION OF THE SYSTEM.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT FSH CALIBRATION READING IS NOT STABLE ON THE AIA-900 ANALYZER. THE CUSTOMER STATED THE FOLLICLE STIMULATING HORMONE (FSH) ANALYTE READINGS WOULD FLUCTUATE MORE THAN 2 STANDARD DEVIATION (SD) FROM THE MEAN TWO DAYS AFTER CALIBRATION AND THE CONTROLS WERE OUT OF RANGE. THE CUSTOMER PERFORMED DECONTAMINATION, CHANGED WASH, DILUENT AND SUBSTRATE BUT STILL HAD OUT OF RANGE CONTROLS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR FOLLICLE STIMULATING HORMONE (FSH). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802648 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1