BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7102740 · Received December 10, 2017

    Report

    Report Number
    8031673-2017-00148
    Event Type
    Malfunction
    Date Received
    December 10, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 8, 2017
    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

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH CUSTOMER AND WAS INFORMED THAT THE ISSUE HAS BEEN RESOLVED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. A (B)(4) COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-600 OPERATOR'S MANUAL UNDER CHAPTER 8: TROUBLESHOOTING INDICATES ALL MECHANICAL ERRORS ARE ASSOCIATED WITH A PARTICULAR SYSTEM, OPERATION, OR COMMUNICATION FUNCTION. ERRORS REQUIRING SOLUTIONS BEYOND THE SCOPE OF THE OPERATOR SHOULD BE REFERRED TO TOSOH BIOSCIENCE, INC. TECHNICAL SERVICE. ALL RECURRING MECHANICAL ERRORS SHOULD BE REPORTED TO TOSOH BIOSCIENCE TECHNICAL SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED THE AIA-600II INSTRUMENT IS SKIPPING A ROW OF TIPS AND INDICATES THAT THE TRAY IS EMPTY. CUSTOMER ALSO REPORTED THAT THE EVEN THOUGH THE DILUENT IS FULL, IT RESETS TO "0", NOT ALLOWING TO RUN QUALITY CONTROLS OVER 400 WITHOUT RESETTING THE HCG (HUMAN CHORIONIC GONADOTROPIN) DILUENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON E2 (ESTRADIOL), PROG (PROGESTERONE), PRL (PROLACTIN), AND BHCG (BETA HUMAN CHORIONIC GONADOTROPIN). 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 E2, PROG, PRL, AND BHCG. 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
    881806 AIA-600II AIA-600II KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1