BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 6844557 · Received September 6, 2017

    Report

    Report Number
    8031673-2017-00021
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 5, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH HI-TEC
    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

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 09-AUG-2017 A FIELD SERVICE ENGINEER REPLACED THE SAMPLER ASSEMBLY IN ORDER TO RESOLVE THE ISSUE. THE FSE CONFIRMED THAT NO RESULTS WERE REPORTED OUT IN ERROR. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOUND NO SIMILAR COMPLAINTS DURING THIS TIME PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-2: LIST OF FLAGS, STATES THAT A <L FLAG IS INDICATIVE OF AN ASSAY RESULT THAT WAS NOT ACCEPTED BECAUSE IT LIES BELOW THE CALIBRATION AREA. THE OPERATOR IS INSTRUCTED TO PERFORM ASSAY AS A COURSE OF ACTION. THE REPORTED ISSUE WAS ATTRIBUTED TO THE SAMPLER ASSEMBLY.

    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. DATE OF EVENT: (B)(6) 2017.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED THAT ON (B)(6) 2017 THE LABORATORY RECEIVED AN ESTRADIOL (E2) RESULT OF <L AND UPON REPEAT THE RESULT WAS 300 PG/ML (NORMAL RANGE 25-3000 PG/ML), WHICH CORRELATED WITH THE PATIENT'S CLINICAL HISTORY. THE ERRATIC RESULT OCCURRED WITH ONE SAMPLE ONLY FOR A HORMONE STIMULATION PATIENT; THE PHYSICIAN EXPECTED THE E2 TO BE INCREASED. THE CUSTOMER REPORTED THAT THIS WAS A SERUM SAMPLE, DRAWN IN PLAIN RED TOP, CLOTTED FOR 20-30 MINUTES AND SPUN 15 MINUTES PER SET CENTRIFUGE. QUALITY CONTROLS (QC) WERE IN RANGE. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627234 AIA-360 AIA-360 KHO TOSOH HI-TEC AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1