BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 9930640 · Received April 6, 2020

    Report

    Report Number
    8031673-2020-00098
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    March 13, 2020
    Report Date
    May 22, 2020
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EKI BOARD AND SAMPLE NOZZLE WERE RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. THE SHIELD WIRE OF THE SAMPLE NOZZLE WAS FRAYED CAUSING BAD CONNECTION TO EKI BOARD. FUNCTIONAL TESTING CONFIRMED THE REPORTED FAILURE OF THE EKI BOARD AND SAMPLE NOZZLE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF EKI BOARD AND SAMPLE NOZZLE.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER'S SITE TO ADDRESS REPORTED EVENT. FSE CONFIRMED THE REPORTED ERROR BY RUNNING A SAMPLE TEST RUN AND ALSO NOTED ERROR 2060 "TIP ATTACHMENT FAILURE BY MAIN ARM" HAD ALSO OCCURRED. WHILE TROUBLESHOOTING, FSE VERIFIED TIP ALIGNMENTS WERE GOOD AND REPLACED THE SAMPLE NOZZLE, BUT ERROR PERSISTED. FSE RESOLVED THE ISSUE BY REPLACING THE EKI BOARD. THE LEVEL DETECT FUNCTION PARAMETERS WERE ADJUSTED AND TESTED BY RUNNING SAMPLES. FSE SUCCESSFULLY RAN DAILY CHECK AND QUALITY CONTROL RUNS WITHOUT ERRORS AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 INSTRUMENT 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 TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGES STATES THE FOLLOWING: TIP DETACHMENT FAILURE BY MAIN ARM. CAUSE: A TIP WAS DETECTED BY TIP DETACHMENT CHECK. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED. (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. TIP ATTACHMENT FAILURE BY MAIN ARM. CAUSE: NO TIP WAS DETECTED BY TIP ATTACHMENT CHECK. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF EKI BOARD.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERROR MESSAGE "2061 TIP DETACHMENT FAILURE BY MAIN ARM" ON THE AIA-2000 INSTRUMENT. THE CUSTOMER REBOOTED INSTRUMENT AND PERFORMED A VERSION UP, BUT ERROR PERSISTED. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF PATIENT SAMPLES FOR FOLLICLE STIMULATING HORMONE (FSH). 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
    391168 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1