BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7372460 · Received March 26, 2018

    Report

    Report Number
    8031673-2018-02235
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    June 22, 2016
    Report Date
    March 26, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TOSOH FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE TO EVALUATE THE PROBLEM. THE FSE REPLACED THE H-8 CPU. FOLLOWING THE FSE RAN SUPPLIER BIO-RAD AND MAC CONTROLS AND ALL RESULTS WERE NEAR THE MEAN VALUES. THE AIA-600II WAS VERIFIED FOR PROPER OPERATION AND RETURNED TO USE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS RELATED TO FAILURE OF THE H-8 CPU. THE AIA-600II SERVICE, OPERATOR'S, AND TRAINING MANUALS WERE REVIEWED AND FOUND TO CLEARLY ADDRESS CALIBRATION, OPERATION, MAINTENANCE, AND TROUBLESHOOTING PERTAINING TO THE AIA-600II SYSTEM. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER CALLED TOSOH TECHNICAL SUPPORT (TTS) TO REPORT THE SUPPLIER BIO-RAD QUALITY CONTROL (QC) RESULTS RUN ON THE AIA-600II ANALYZER ARE FLUCTUATING EVEN THOUGH THEY ARE WITHIN ACCEPTABLE RANGE. THE CUSTOMER INDICATED THAT QCS WERE NOT TAKEN FROM THE SAME SAMPLE CUP AND THE QC SITS OUT TO WARM UP FOR 10 MINUTES PRIOR TO RUNNING. THE CUSTOMER FURTHER REPORTED THAT THEIR QC RESULTS ARE NOT IN LINE WITH PEER RANGES, WHICH ARE BASED ON A SMALL NUMBER OF LABS. PEER RANGES REPORTED AS: 0.238, SD 0.032, L2 15.22 - SD 1.01 AND 85.89 - SD 3.56. THE CUSTOMER INDICATED THAT THEY TRIED CALIBRATING WITH NEW REAGENTS AFTER PERFORMING DECONTAMINATION OF THE INSTRUMENT, MAKING NEW SUBSTRATE, AND CLEANING THE WASH PROBE BUT THE PROBLEM PERSISTS. TTS TOLD THE CUSTOMER THAT THEY WOULD SEND OUT A NEW REAGENT LOT FOR CALIBRATION AND ADVISED THE CUSTOMER TO CALIBRATE WITH THE NEW LOT AND THEN RUN QCS. THE CUSTOMER ENDED UP RECEIVING THE SAME LOT USED IN PRIOR CALIBRATION AND CALLED BACK TO REQUEST A FIELD SERVICE ENGINEER (FSE) TO COME TO THE CUSTOMER SITE AND EVALUATE THE PROBLEM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF CKMB AND CTNL 2 PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215272 AIA-600II AIA-600II KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1 BIO-RAD LOT 23610