BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000 ST

    MDR report key: 16971429 · Received May 21, 2023

    Report

    Report Number
    3004529019-2023-00332
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 22, 2023
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284616
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) CONDUCTED A SITE VISIT AND WAS ABLE TO CONFIRM THE PROBLEM BY REVIEWING THE ERROR LOG. THE REPORTED ISSUE WAS INTERMITTENT AND FSE VERIFIED THE SENSING PARAMETERS IN THE MAINTE PROGRAM (MAINTENANCE SCREEN) AND IDENTIFIED DECREASED SENSITIVITY WITH THE SAMPLING NOZZLE AND EKI BOARD. FSE REPLACED THE SAMPLING NOZZLE, THE LIQUID SURFACE DETECTION BOARD (EKI BOARD), AND PERFORMED LEVEL DETECT PARAMETER ADJUSTMENT WHICH RESOLVED THE REPORTED ISSUE. THE CUSTOMER VALIDATED THE ANALYZER BY PERFORMING QUALITY CONTROL (QC). THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) THROUGH THE AWARE DATE. THERE WERE TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-2000 OPERATORS MANUAL UNDER APPENDIX 4: ERROR MESSAGES STATE THE FOLLOWING: 2075] AIR DETECTED DURING SPECIMEN SUCTION BY MAIN ARM CAUSE : AFTER SPECIMEN SUCTION, IT WAS DETERMINED THAT THE TIP FAILED TO TOUCH THE LIQUID SURFACE EVEN THOUGH THE SPECIMEN LEVEL WAS 2 MM OR HIGHER THAN THE BOTTOM OF THE CONTAINER. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION : ENSURE THAT THE SPECIMEN IS IN THE CORRECT POSITION AND IS FREE FROM BUBBLES. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE SAMPLING NOZZLE AND EKI BOARD.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING ERROR MESSAGE "2075 AIR DETECTED DURING SPECIMEN SUCTION BY MAIN ARM" ON THE AIA-2000 ANALYZER WHEN PERFORMING DILUTION. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED ISSUE WHICH CAUSED DELAY IN REPORTING BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), ESTRADIOL (E2), FOLLICLE STIMULATING HORMONE (FSH), LUTEINIZING HORMONE (LH II), PROLACTIN (PRL) AND INTACT PARATHYROID HORMONE (IPTH) PATIENT SAMPLES. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760514 AIA-2000 ST FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 ST 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown