BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 6867215 · Received September 14, 2017

    Report

    Report Number
    8031673-2017-00028
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 15, 2017
    Report Date
    December 28, 2017
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: 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. DEVICE EVALUATION BY MANUFACTURER: INVESTIGATION INTO THIS ISSUE CONFIRMED THAT ON 14-AUG-2017 A FIELD SERVICE ENGINEER (FSE) PERFORMED PERIOD MAINTENANCE ON THE AIA-900, WHICH INCLUDED ADJUSTING THE INCUBATOR TEMPERATURE. THE FSE ADVISED THE OPERATOR AT THE TIME OF THE PM TO RE-CALIBRATE ALL ASSAYS DUE TO THE INCUBATOR TEMPERATURE ADJUSTMENT. ON 15-AUG-2017 A FIELD SERVICE ENGINEER CALLED THE CUSTOMER AND EXPLAINED THAT THE OPERATOR PRESENT DURING THE PM HAD BEEN ADVISED TO RE-CALIBRATE ALL ASSAYS AFTER THE INCUBATOR TEMPERATURE ADJUSTMENT. ON (B)(6) 2017 THE CUSTOMER REPORTED THAT AFTER RE-CALIBRATION OF ALL ASSAYS, QC AND PATIENT RESULTS WERE RECOVERING WITHIN ACCEPTABLE RANGE. THE AIA-900 IS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOUND NO OTHER SIMILAR COMPLAINTS DURING THIS TIME PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 1, BASIC PRECAUTIONS, STATES THAT TO ENABLE CORRECT MEASUREMENT RESULTS TO BE ACQUIRED AT ALL TIMES, IT IS NECESSARY TO CORRECTLY CONTROL THE INSTRUMENT AND THE REAGENTS ACCORDING TO THE STIPULATED CONTROL STANDARDS. TO CHECK WHETHER OR NOT THE INSTRUMENT AND THE REAGENTS EXHIBIT THE SPECIFIED PERFORMANCE, MEASURE THE CONTROL AT CONSTANT INTERVALS, AND CONFIRM THAT THE RESULTS ARE WITHIN THE CONTROL RANGE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ATTRIBUTED TO THE AIA-900 NOT BEING RE-CALIBRATED BY THE OPERATOR AFTER ADJUSTMENT OF THE INCUBATOR TEMPERATURE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED DISCREPANT PATIENT RESULTS ON ESTRADIOL (E2) AND PROGESTERONE (PROG III). ALL IMPACTED SAMPLES WERE ON THE SAME RUNS ON DIFFERENT DATES: ESTRADIOL: 14-AUG-2017, 15-AUG-2017. PATIENT 1 = 79 PG/ML, 62 PG/ML. PATIENT 2 = 141 PG/ML, 106 PG/ML. PATIENT 3 = 74 PG/ML, 52 PG/ML. NORMAL ASSAY RANGE IS 25-3000 PG/ML. PROGESTERONE: 14-AUG-2017, 15-AUG-2017. PATIENT 1 = 0.63 NG/ML , 0.39 NG/ML. PATIENT 2 = 0.37 NG/ML , 0.18 NG/ML. PATIENT 3 = 0.59 NG/ML , 0.38 NG/ML . NORMAL ASSAY RANGE IS 0.1-40 NG/ML. THE CUSTOMER REPORTED THAT QUALITY CONTROLS (QC) ON E2 AND PROG III WERE RECOVERING HIGH AS WELL; THEREFORE, NO PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT QUALITY CONTROLS WERE RUNNING OUT OF RANGE HIGH AFTER A FIELD SERVICE ENGINEER HAD ADJUSTED THE INCUBATOR TEMPERATURE DURING PERIOD MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644033 AIA-900 AIA-900 KHO TOSOH HI-TEC AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1