BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7308687 · Received March 1, 2018

    Report

    Report Number
    8031673-2018-01721
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    January 6, 2016
    Report Date
    March 1, 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

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO REPLACED THE BENT SAMPLE PROBE AND VERIFIED ALL SAMPLE PROBE ALIGNMENTS USING COMPOUND ACTION TEST. FSE THEN CHECKED ALL TURN TABLE SAMPLE HOLDER TUBE SLOTS AND FOUND THAT SPOT #1 HAD BROKEN PLASTIC CLIPS AND NOT HOLDING TUBE STRAIGHT. FSE REPLACED THE TURN TABLE SAMPLE HOLDER TO CORRECT ISSUE. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS A BROKEN CLIPS ON TUBE HOLDER. 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) 2016 A CUSTOMER REPORTED AN ERROR 2012 (AIR DETECTED IN DILUENT) WITH THEIR AIA-360 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2016 TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR BHCG PATIENT RESULT. THERE WAS 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
    149439 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1