BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 18332945 · Received December 14, 2023

    Report

    Report Number
    3004529019-2023-00482
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 22, 2023
    Report Date
    December 15, 2023
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189283992
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 REPORTED PROBLEM BY REVIEWING THE ERROR LOG. THE FSE NOTED THE ANALYZER WAS NOT DOWN UPON ARRIVAL AND NO ERRORS WERE OCCURRING. THE CUSTOMER HAD PROVIDED THE FSE WITH A VIDEO RECORDING OF THE ISSUE OCCURRING AND THE FSE IDENTIFIED THE PICK UP ASSEMBLY CLAWS WERE SLIGHTLY HITTING THE TEST CUP AS THE CLAW WAS GOING DOWN TO PICK UP THE TEST CUP. THE CUSTOMER CONFIRMED THE ISSUE WAS OCCURRING INTERMITTENTLY. THE FSE ADJUSTED THE CLAW OPENING TO ENSURE THE CLAW CLEARED THE TEST CUP WITH ROOM TO PICK UP THE TEST CUP WITH NO ERRORS. THE FSE RAN SEVERAL CUP TRANSFER TEST ALONG WITH THE CUSTOMER RUNNING TEST AND NO ISSUES RECURRING. THE FSE VALIDATED THE ANALYZER BY RUNNING QUALITY CONTROL (QC) WITH RESULTS WITHIN ACCEPTABLE RANGE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED THRU THE AWARE DATE FOR THE SERIAL NUMBER (B)(6). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [2161] C.TRANSFER CUP PICKUP FAILURE CAUSE: THE CUP SENSOR S063 FAILED TO DETECT THE CUP AFTER THE CUP WAS GRASPED. ACTION: PLEASE CONTACT THE TOSOH LOCAL REPRESENTATIVES. CHECK S063, THE CUP PICKUP POSITION, AND THE CUP PICKUP OPERATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN ALIGNMENT ISSUE WITH THE TEST CUP ASSEMBLY CLAW, COMPONENT FAILURE.

    Description of Event or Problem · 0

    A CUSTOMER 2161 (900 ONLY) C.TRANSFER CUP PICKUP FAILURE ON THE AIA-900 ANALYZER. THE CUSTOMER CONFIRMED ALL SET HOME ACTION COMPLETES, BUT THE ANALYZER WILL NOT EMPTY TEST CUPS FROM THE INCUBATOR. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR INTACT PARATHYROID HORMONE (IPTH). THERE IS 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
    2299689 AIA-900 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-900 N/A 04560189283992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown