BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7323067 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-01945
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    July 26, 2016
    Report Date
    March 8, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE (B)(6) 2016 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE WAS INFORMED THAT THE CUSTOMER RESOLVED THE LOW CONTROL RECOVERY BY DECONTAMINATED THE INSTRUMENT. THE PROBABLE CAUSE OF THE EVENT IS DUE TO CONTAMINATION OF THE INSTRUMENT. 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 THE (B)(6) 2016 THE CUSTOMER REPORTED LOW CONTROL RECOVERY FOR TESTOSTERONE. THE IN- HOUSE RANGES FOR TESTOSTERONE FROM 11 LABS. THREE LOTS OF BIO RAD WERE RUN ON THE INSTRUMENT AND THE RESULTS WERE LOW COMPARE TO THE 11 LABS RANGE. CUSTOMER INDICATED THAT ALL 11 SITES USE THE SAME TESTOSTERONE CUP LOT AND CALIBRATOR LOT. ALSO, ALL CALIBRATION CURVES HAVE CALIBRATOR 1 RATES ARE IN THE 80'S. THE CUSTOMER IS USING TESTOSTERONE CONTROL LOT G212451 AND CALIBRATOR LOT 6232468. THE CALIBRATION CURVE FROM (B)(6) 2016 RATES ARE CONSISTENT. THE CUSTOMER INDICATED THAT THEY ARE EXPERIENCING LOW CONTROLS ON E2. THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE (B)(6) 2016 FOR FURTHER INVESTIGATION. THE REPORTED ISSUE WITH THEIR AIA-360 INSTRUMENT HAS THE POTENTIAL FOR DELAY IN REPORTING PATIENT RESULT FOR E2. 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
    169161 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Death