BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 9513206 · Received December 23, 2019

    Report

    Report Number
    8031673-2019-00513
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 26, 2019
    Report Date
    December 9, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. THE FSE WAS ABLE TO CONFIRM AND REPRODUCE THE ISSUE BY ATTEMPTING TO PERFORM LEVEL SENSE AND RECEIVING ERROR 2013. THE ISSUE WAS RESOLVED BY REPLACING PC BOARD FOR THE LEVEL SENSOR (EKI BOARD). THE INSTRUMENT WAS VALIDATED BY RUNNING QUALITY CONTROLS (QC). THE QC RESULTS PASSED AND WERE WITHIN PUBLISHED RANGES. THE INSTRUMENT SOFTWARE WAS UPGRADED TO VERSION (B)(4). NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-360 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 26OCT2018 THROUGH AWARE DATE 26NOV2019. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE REVIEW PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-1: LIST OF ERROR MESSAGES AND 7-2: LIST OF FLAGS STATES THE FOLLOWING: MF: A FLAG IS ATTACHED DUE TO AN ABNORMALITY OCCURRING DURING SAMPLE DISPENSING. OPERATION CONTINUES BUT A RETURN FAILURE DISABLES THE ASSAY. 2013 - SAMPLE LEVEL DETECTION: DESCRIPTION: THE LIQUID SURFACE CANNOT BE DETECTED EVEN AT THE BOTTOM OF THE SAMPLE CUP OR THE BLOOD SAMPLE TUBE. TROUBLESHOOTING: CONTACT THE SERVICE DEPARTMENT. THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE EKI (PCB) BOARD FOR LEVEL SENSOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING A MF MECHANICAL FAILURE WHILE SAMPLING FLAG AND ERROR MESSAGE 2013 SAMPLE LEVEL DETECTION ON THE AIA-360 INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), ESTRADIOL (E2) AND LUTEINIZING HORMONE (LH II) 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
    1304220 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1