BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8364856 · Received February 24, 2019

    Report

    Report Number
    8031673-2019-00027
    Event Type
    Malfunction
    Date Received
    February 24, 2019
    Date of Event
    January 4, 2019
    Report Date
    June 9, 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

    THE 2-WAY SOLENOID VALVE WAS RETURNED TO THE INSTRUMENT SERVICE CENTER (ISC) FOR INVESTIGATION. FUNCTIONAL TESTING ON THE RETURNED 2-WAY SOLENOID VALVE. THE REPORTED EVENT COULD NOT BE DUPLICATED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED POSSIBLY DUE TO THE PROBLEM BEING INTERMITTENT WITH THE 2-WAY SOLENOID VALVE (SV402). 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.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. FSE ARRIVED ON SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE ISSUE BY REVIEWING THE API REPORT. NEXT, FSE PERFORMED PERIODIC MAINTENANCE (PM), REPLACED THE SOLENOID VALVE (SV402), ADJUSTED THE INCUBATOR TEMPERATURE TO 37.0 CELSIUS, AND THEN RECALIBRATED E2 AND RAN QUALITY CONTROL (QC) ALONG WITH API SPECIMENS WITHOUT ISSUE. ALL API SPECIMENS WERE NOW IN RANGE. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM 04DEC2017 THROUGH AWARE DATE (B)(4) 2019. 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED; INVESTIGATION IS CURRENTLY IN-PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE OUT OF (B)(6) PROFICIENCY SAMPLES FOR ESTRADIOL (E2) FAILED WITH THEIR AIA-360 ANALYZER. THE CUSTOMER RETAINED THE SAMPLE IN THEIR FREEZER FOR FURTHER TESTING AND SENT THE RESULTS TO TECHNICAL SUPPORT (TS) FOR REVIEW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158310 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1