BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 13880290 · Received March 24, 2022

    Report

    Report Number
    3004529019-2022-00061
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 15, 2022
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189282896
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEERING (FSE) WAS AT THE CUSTOMER'S SITE TO ADDRESS REPORTED EVENT. FSE CONFIRMED THE COMPLAINT BY REVIEWING THE ERROR LOGS AND REPRODUCED ERROR BY RUNNING SAMPLES. WHILE TROUBLESHOOTING, A BROKEN LIQUID SENSE GROUND WIRE WAS FOUND AND REPLACED WHICH RESOLVED THE COMPLAINT. FSE SUCCESSFULLY PERFORMED DAILY CHECK AND QC RUNS WITHOUT ERROR AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-360 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 7, SECTION 7.1: LIST OF ERROR MESSAGES STATES THE FOLLOWING: [2011] AIR DETECTED [SAMPLE] IS GENERATED WHEN THERE IS NO CONTACT WITH THE LIQUID SURFACE AFTER SAMPLE SUCTION. 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO BROKEN GROUND WIRE.

    Additional Manufacturer Narrative · 0

    THE LIQUID SENSE GROUND CABLE WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. VISUAL INSPECTION FOUND THAT THE ATTACHMENT RING OF THE GROUND CABLE WAS DETACHED FROM THE WIRE, CONFIRMING THE REPORTED EVENT WAS DUE TO BROKEN GROUND WIRE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO BROKEN LIQUID SENSE GROUND WIRE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING "MECHANICAL FAILURE (MF) FLAG" AND "2011 AIR DETECTED [SAMPLE]" ERROR DURING QUALITY CONTROL RUN ON THE AIA-360 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), ESTRADIOL (E2), LUTEINIZING HORMONE (LHII) AND PROGESTERONE (PROGII). 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
    716294 AIA-360 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-360 IMMUNOASSAY ANALYZER N/A 04560189282896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown