BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 12502966 · Received September 20, 2021

    Report

    Report Number
    3004529019-2021-00032
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    July 23, 2021
    Report Date
    September 21, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED IN RESPONSE TO A COMPLAINT OF AIR DETECTED DURING DILUENT SUCTION ON THE AIA 2000 ANALYZER. THE DEVICE WAS BEING USED FOR DIAGNOSIS DURING THE COMPLAINT EVENT. AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER (FSE) CONFIRMED THE ERROR IN THE ERROR LOG AND REPLACED THE SAMPLE NOZZLE AND THE EKI BOARD. THE SAMPLE NOZZLE EXHIBITED DECREASED SENSITIVITY TRACED TO A COMPONENT FAILURE. THE EKI BOARD EXHIBITED AN ELECTRICAL PROBLEM TRACED TO A COMPONENT FAILURE. NEITHER PRODUCT WAS NOT RETURNED FOR A PRODUCT EVALUATION. THE EKI BOARD AND CONTAMINATED SAMPLE NOZZLE WERE DISCARDED AT THE CUSTOMER BIOHAZARD WASTE. REVIEW OF THE INVESTIGATION CONCLUSIONS INDICATES THAT ESCALATION OF THE COMPLAINT FOR CORRECTIVE AND PREVENTIVE ACTIONS IS NOT WARRANTED. A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FROM DATE OF (B)(6) 2020 THROUGH AWARE DATE (B)(6) 2021 WAS PERFORMED FOR SIMILAR COMPLAINTS. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER SECTION 04 - ERROR MESSAGES STATES THE FOLLOWING: [2085] AIR DETECTED DURING DILUENT SUCTION BY MAIN ARM. CAUSE: DURING DILUENT SUCTION, IT WAS DETERMINED THAT THE TIP FAILED TO TOUCH THE LIQUID SURFACE. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (DS FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN AIR DETECTED DURING DILUENT SUCTION ERROR 2085 ON THE AIA-2000 ANALYZER WHILE RUNNING QUALITY CONTROLS (QC). THE SITE PRIMED THE WASH AND DILUENT, MADE NEW WASH AND DILUENT AND PRIMED AGAIN WITH NO ERROR. CUSTOMER CLEANED THE PROBE AND REBOOTED THE ANALYZER AND IT DID NOT RESOLVE THE ERROR. THE SITE RUNS CATEGORY A ANALYTE ALPHA-FETOPROTEIN (AFP) DAILY AND IT IS NOT BATCHED. THIS IS A REPORTABLE EVENT BASED ON DELAY IN REPORTING OF PATIENT RESULTS FOR AFP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400535 AIA-2000 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 ST N/A 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1