BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-2000

    MDR report key: 7404684 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-04482
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 2, 2016
    Report Date
    April 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. ON 03-MAR-2016, AN FSE VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE EVALUATED THE SENSOR DRAIN WELL AND DRAIN SHELF FOR LEAKS BUT DID NOT OBSERVE ANY. THEY ALSO CHECKED THAT THE WASTE FUNNEL BEHIND THE SUBSTRATE COMPARTMENT WAS DRAINING WITHOUT ISSUE HOWEVER, THE LEAK SENSOR WAS IN WORKING CONDITION BUT THE LQD BOARD WAS BAD AND NEEDED TO BE REPLACED. FSE ORDERED THE PART AND RETURNED ON 04-MAR-2016 TO REPLACE THE PART. HOWEVER, THE ERROR RECURRED WHILE RUNNING CONTROLS AND SAMPLES. FSE FOUND THAT THE LEAK SENSOR AND THE MAIN BOARD HAD GONE BAD. FSE REPLACED THE COMPONENTS AND THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A BAD B/F LEAK SENSOR.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED ERROR 3005 (LEAK SENSOR ERROR) WITH THEIR A1A-2000 ANALYZER. THE CUSTOMER COULD NOT OBSERVE ANY LIQUID AND TRIED RESTARTING THE RUN BUT HE ERROR REOCCURRED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING LUTEINIZING HORMONE (LHII) AND ESTRADIOL (E2) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245096 A1A-2000 A1A-2000 KHO TOSOH CORPORATION A1A-2000

    Patients

    Seq Age Sex Outcome Treatment
    1