BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7327267 · Received March 9, 2018

    Report

    Report Number
    8031673-2018-01655
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 8, 2017
    Report Date
    March 9, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2017 VIA A PHONE CONVERSATION, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT SPECIALIST (TSS) THAT THE BIORAD QC LOT 40330 WAS 245, 621, 1316 PG/ML. ALL QUALITY CONTROL RUNS WERE NOTED TO BE WITHIN QC TARGET RANGE BY TSS. E2 WAS LAST CALIBRATED ON (B)(6) 2017 WITH CUP LOT GX129A1/CAL LOT G632971. TSS DISCUSSED RUNNING A CORRELATION STUDY BETWEEN THE TWO METHODS TO DETERMINE THE RELATIONSHIP BETWEEN THE TWO METHODOLOGIES. THE SECOND METHOD IS UNKNOWN AT THIS TIME. THE PROBABLE CAUSE OF THE EVENT WAS LACK OF OPERATOR UNDERSTANDING OF THE TWO TEST METHODOLOGIES. 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 (B)(6) 2017 A CUSTOMER REPORTED CONCERNS WITH THEIR E2 RESULTS WITH THEIR AIA-600II. WHEN THE SAMPLES WERE SENT OUT THE RESULTS CAME BACK DIFFERENT. AN EXAMPLE PROVIDED BY THE SITE REVEALED "E2 - 647 PG/ML AND WHEN SENT OUT IT CAME BACK AS 406 PG/ML." THE CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. THE REPRESENTATIVE FROM THE TECHNICAL SUPPORT SPECIALIST (TSS) SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE REPORTED EVENT WHICH RESULTED IN DISCREPANT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT RESULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169313 AIA-600II AIA-600II KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1