BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7267376 · Received February 13, 2018

    Report

    Report Number
    8031673-2018-01102
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    October 26, 2017
    Report Date
    February 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO AN INTERNAL NONCONFORMANCE IDENTIFIED. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE SPOKE WITH THE CUSTOMER AND ADVISED HER TO RUN A TEST CUP READ UNDER MAINTENANCE. THE ANALYZER WAS ABLE TO READ ALL OF THE CUPS. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL (B)(4) FROM 26-AUGUST-2016 THROUGH (B)(6) 2017 FOR SIMILAR COMPLAINTS WAS PERFORMED. THERE WERE WAS ONE SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 FLAGS AND ERRORS IS AS FOLLOWS: INSTRUMENT FLAG: LS, CALCULATION FLAG: BLANK, DECISION FLAG: BLANK, PRIORITY FLAG: LS, RATE VALUE: BLANK, CONC. VALUE: BLANK, ASTM FLAG: A, TO HOST: 0/BLANK. LS MEASUREMENT CANNOT TAKE PLACE DUE TO INSUFFICIENT SPECIMEN DILUTING SOLUTION. PRINT AND DISPLAY (RATE VALUE) : BECOMES BLANK. PRINT AND DISPLAY (CONCENTRATION VALUE) : BECOMES BLANK. RS232C OUTPUT (CONCENTRATION VALUE) : CONFORMS TO THE SETTING THAT IS APPLICABLE TO THE CASE WHERE NO CONCENTRATION IS SET IN THE HOST. RS232C OUTPUT (FLAG) : A (NOTE: RS232C OUTPUT (FLAG) GENERATES THE "A" FLAG) THE MOST PROBABLE CAUSE FOR LS FLAGS WAS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED RECEIVING RANDOM LS FLAGS ON THE AIA-900 INSTRUMENT. CUSTOMER NOTED THAT THE ERROR WAS RELATED TO A CUP READER ISSUE. THE CALIBRATION WILL FAIL DUE TO MULTIPLE LS FLAGS BEING SET AT DIFFERENT LOCATIONS WITHIN HER CALIBRATION RACK. CUSTOMER IS UNABLE TO RUN QUALITY CONTROL SAMPLES ON BHCG REPRODUCTIVE HORMONE. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR BHCG REPRODUCTIVE HORMONE. 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
    112083 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1