BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7347850 · Received March 18, 2018

    Report

    Report Number
    8031673-2018-02923
    Event Type
    Malfunction
    Date Received
    March 18, 2018
    Date of Event
    August 24, 2016
    Report Date
    March 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. ON 30 AUGUST 2016 THE FSE DECONTAMINATED THE DILUENT/WASH/SUB SYSTEMS AND REPLACED THE DILUENT PUMP AND SUBSTRATE SYRINGE. THE ENGINEER RAN PRECISION ON TT3 LEVEL 2 WITH COEFFICIENT OF VARIATION (CV) OF 1.7%. THE ENGINEER RAN PATIENT SAMPLE OF LHII WITH A RESULT MEAN OF 1.81 AND RECEIVED 9 1.8S AND 1 1.0, THEN RAN LEVEL 1 BIO-RAD AND GOT A CV OF 4.4%. ALL WITHIN SPEC HOWEVER THE FSE WANTED TO RUN A LOWER RATE SAMPLE. THE ENGINEER RETURNED ON 31 AUGUST 2016 AND RAN CALIBRATOR ZERO AS A PATIENT, THE ENGINEER OBSERVED MULTIPLE FLIERS DURING A TEN REPLICATION PRECISION RUN. THE FSE REPLACED THE NOZZLE AND SAMPLE SYRINGE ASSY. DURING ADJUSTMENT OF THE LIQUID LEVEL SENSE ON THE EKI BOARD THE POTENTIOMETER BROKE ON THE BOARD. AN EKI REPLACEMENT BOARD WAS ORDERED AND THE EKI BOARD AND NOZZLE WERE REPLACED. THE ENGINEER RAN REPAIRED TUBING FROM THE NOZZLE TO THE SAMPLE SYRINGE AND REPLACED THE SUBSTRATE SOLENOID, WHICH THE ENGINEER REPORTED WAS THE FINAL FIX TO THE PROBLEM. PRECISION WAS RUN ON SEVERAL DIFFERENT MATERIALS, CALIBRATION AND CONTROLS WERE ALL REPORTED TO BE ACCEPTABLE. THE AIA-900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS THE SUBSTRATE 3 WAY SOLENOID VALVE

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED LHII PRECISION, OCCASIONAL HIGH FLIERS ON QUALITY CONTROL (QC). TECHNICAL SUPPOT(TS) WORKED WITH THE CUSTOMER AND UPON REVIEW OF A PATIENT SAMPLE THAT WAS RUN TEN TIMES TS NOTED THE RESULTS INDICATED AN OCCASIONAL E2 FLIER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING LHII PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OR POTENTIAL DISCREPANT PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190688 AIA-900 AIA-900, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1