BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8857782 · Received August 2, 2019

    Report

    Report Number
    8031673-2019-00271
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 2, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DISTRIBUTOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING EVALUATION, THE FSE FOUND A LOOSE GROUND CABLE FROM LEVEL SENSING PCB. THE FSE VERIFIED AND PROPERLY INSTALLED ALL CABLES CORRECTLY. THE FSE ALSO PERFORMED ADJUSTMENTS TO SAMPLE LEVEL SENSE, ASPIRATION POSITION, CLOG VOLTAGE AND HAND TOUCH AD OF THE ANALYZER. THE FSE SUCCESSFULLY COMPLETED QC RUN. NO FURTHER ACTION REQUIRED BY THE FSE. 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 IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO LOOSE CONNECTION OF THE LEVEL SENSING PCB BOARD.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO THE DISTRIBUTOR GETTING MECHANICAL FAILURE (MF) ERROR FLAG DURING QUALITY CONTROL (QC) RUN WITH THE AIA-360 INSTRUMENT. A DISTRIBUTOR FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAY OF PROGESTERONE (PROG II) ANDCARDIAC TROPONIN I (CTNL2) 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
    650760 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1