BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7326055 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-00165
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 8, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. ON (B)(4) 2018, A FIELD SERVICE ENGINEER (FSE) REPLACED THE BENT SAMPLE NOZZLE ASSEMBLY, WHICH WAS MOST LIKELY CAUSED BY AN INTERMITTENT FAILURE OF THE CABLE FROM CN217 TO PM202. THE CABLE WAS FROM CN217 TO PM202 WAS ALSO REPLACED. THE FSE CHECKED ADJUSTMENTS AND LUBRICATED THE SAMPLER ASSEMBLY. THE FSE FOUND THE TURN TABLE SAMPLE TUBE HOLDER AT POSITION 1 WITH BROKEN PRONGS. THE FSE REPLACED THE TURN TABLE SAMPLE TUBE HOLDER. THE FSE THEN PROCEEDED TO RUN BIORAD QUALITY CONTROLS FOR ESTRADIOL (E2), WHICH RESULTED WITH THE LOW LEVEL QC RECOVERING OUT OF RANGE LOW, WHICH WAS WITHIN RANGE AFTER RECALIBRATING THE AIA-360. THE AIA-360 WAS WORKING WITHIN SPECIFICATIONS, NO FURTHER ACTION WAS REQUIRED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS FOR SERIAL NUMBER (B)(4) WAS CONDUCTED FROM 06-JAN-2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-1: LIST OF ERROR MESSAGES, STATES THE FOLLOWING: IF AN ERROR OCCURS, THE DEVICE STOPS AND THE MESSAGE SHOWN BELOW IS DISPLAYED. IF AN ERROR MESSAGE IS DISPLAYED DURING AN ASSAY, YOU MAY NOT BE ABLE TO CONTINUE THE ASSAY. THE 4020 SPEC.Z-AXIS HOME OVERRUN. DESCRIPTION: THE SPECIMEN Z-AXIS MOTOR OVERRAN ON THE HOME SIDE. TROUBLESHOOTING: TURN THE POWER OFF AND ON AGAIN. IF THIS PROBLEM REOCCURS, CONTACT THE SERVICE DEPARTMENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULTY CABLE CN217 TO PM202.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED 4020 SPEC.Z-AXIS HOME OVERRUN ERROR MESSAGE WHILE RUNNING PATIENT SAMPLES ON THE AIA-360 INSTRUMENT. THE CUSTOMER ALSO REPORTED HEARING A GRINDING SOUND WHEN THE ERROR MESSAGE WAS GENERATED. THE TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO REMOVE THE BACK PANEL OF THE AIA-360 INSTRUMENT FOR INSPECTION; THE CUSTOMER FOUND THAT THE SAMPLE NEEDLE ASSEMBLY WAS BENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR ESTRADIOL (E2), LUTEINIZING HORMONE (LHII), FOLLICLE STIMULATING HORMONE (FSH), AND PROGESTERONE (PROG). 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
    166214 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1