BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8338973 · Received February 14, 2019

    Report

    Report Number
    8031673-2019-00023
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 14, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. A 13 MONTH COMPLAINT AND SERVICE HISTORY REVIEW WAS PERFORMED FOR ST AIA-PACK ESTRADIOL TEST CUP LOT NUMBER I812915 FROM 28DEC2017 THROUGH 28JAN2019. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE ESTRADIOL ST AIA-PACK PACKAGE INSERT STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G. SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). EXPECTED VALUES EACH LABORATORY SHOULD DETERMINE A REFERENCE INTERVAL WHICH CORRESPONDS TO THE CHARACTERISTICS OF THE POPULATION BEING TESTED. AS WITH ALL DIAGNOSTIC PROCEDURES, CLINICAL RESULTS MUST BE INTERPRETED WITH REGARD TO CONCOMITANT MEDICATIONS ADMINISTERED TO THE PATIENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED SEEING DIFFERENCES IN ESTRADIOL (E2) PATIENT RESULTS BETWEEN THEIR AIA-360 ANALYZER AND ROCHE E601 ANALYZER. THE CUSTOMER REPORTED RUNNING ST AIA-PACK ESTRADIOL TEST CUP LOT NUMBER I812915 WITH THE AIA-360 ANALYZER WHILE THE ROCHE E601 ANALYZER USED EIII. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLES WERE SENT OUT TO A REFERENCE LAB FOR CONFIRMATION. THE CUSTOMER STATED THAT ON ONE (1) PATIENT THE E2 RESULT WAS 3541 PG/ML AND ON A SECOND PATIENT THE E2 RESULT WAS 1711 PG/ML AT THE REFERENCE LAB. THESE TWO PATIENTS HAD RECENTLY OBTAINED E2 RESULTS OF 2275 PG/ML AND 1711 PG/ML RESPECTIVELY ON THE AIA-360 ANALYZER. THE CUSTOMER CONFIRMED THAT THE PATIENT SAMPLES SENT OUT TO THE REFERENCE LAB WERE NOT RUN ON THE AIA-360 ANALYZER. THE CUSTOMER WAS COMPARING EXPECTED RESULTS FROM THE AIA-360 TO RESULTS OBTAINED WITH THE ROCHE E601 ANALYZER. THE CUSTOMER CONFIRMED THAT NO METHOD VALIDATION HAD BEEN DONE WITH THE REFERENCE LAB. THE TECHNICAL SUPPORT SPECIALIST WAS NOT ABLE TO DETERMINE WHETHER CORRELATION STUDIES HAVE BEEN DONE BY THE CUSTOMER BETWEEN THE AIA-360 ANALYZER AND THE ROCHE E601 ANALYZER EITHER. THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO TOO MANY VARIABLES, WHICH COULD HAVE IMPACTED THE DIFFERENCE IN RESULTS; THE METHODOLOGY, THE SAMPLES, AND THE ANALYTES (E2 VS. E3) WERE DIFFERENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133947 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1