BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7403814 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-03741
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    October 26, 2015
    Report Date
    April 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. TS EXPLAINED THAT THEY NEED TO USE SUFFICIENT QUANTITY OF SAMPLE IN SAMPLE CUP FOR ANALYSIS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS AN INCORRECT SAMPLE AMOUNT PLACED IN CUP BY USER.

    Description of Event or Problem · 0

    ON (B)(6) 2015 THE CUSTOMER REPORTED FAILED API WITH THEIR AIA-900 ANALYZER. CUSTOMER REPORTED FAILED API THIRD EVENT FOR PROG, TEST, AND PROLACTIN WITH IA-06. ALL RESULTS LOW. PRL 2.9 AND MEAN 12.31, TEST 0.8 AND RANGE 7-10 PROG RESULT 0.8 AND RANGE 31-42. NO ANALYZER FLAGS OR ERRORS. CUSTOMER REPEATED API TODAY AND ALL RESULTS IN GRADED RANGE. THIS COMPLAINT WAS DEEMED TO BE REPORTABLE AND CLASSIFIED AS A LEVEL-2 EVENT DUE TO A POTENTIALLY API DISCREPANCY AND TO A POTENTIAL DELAY IN REPORTING OF PATIENT RESULTS FOR PROG AND PRL. THESE ARE CLASSIFIED AS CATEGORY A ASSAYS AS DEFINED IN DELAYED RESULT REPORTABILITY DETERMINATION (10-QAG-013-2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247130 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1