BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8185875 · Received December 20, 2018

    Report

    Report Number
    8031673-2018-05326
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 20, 2018
    Report Date
    February 15, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4), WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEERING (FSE) WAS AT CUSTOMER'S SITE TO RESOLVE REPORTED EVENT. FSE CONFIRMED CUSTOMER'S COMPLAINT. FSE REALIGNED TIP DISPOSAL CHUTE AND CLEANED THE CHUTE. FSE VERIFIED PROPER OPERATION WITHOUT ANY ERRORS. FSE SUCCESSFULLY RAN DAILY CHECK AND QUALITY CONTROLS WITHOUT ANY ERRORS. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 INSTRUMENT IS FUNCTIONING AS EXPECTED. THE AIA-900, SERIAL NUMBER (B)(6), WAS INSTALLED ON (B)(6) 2018. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM INSTALLATION DATE THROUGH AWARE DATE. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: TIP REMOVAL ERROR IS GENERATED WHEN A TIP IS DETECTED DURING THE TIP REMOVAL CHECK. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: IF THE TROUBLE REOCCURS, CONTACT THE TOSOH LOCAL REPRESENTATIVES. SAMPLE-Z BUMP ERROR IS GENERATED WHEN THE SPECIMEN CAP REAR-END COLLISION SENSOR S054 WAS ACTIVATED WHILE THE SPECIMEN DISPENSING ARM Z WAS MOVING TOWARD THE HOME POSITION. A SS FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: IF THE CAP IS ON THE SPECIMEN, REMOVE IT AND PERFORM MEASUREMENT ONCE AGAIN. IF IT IS NOT, CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S054 AND PM051 FOR A POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO MISALIGNMENT OF TIP REMOVAL

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 2062 TIP REMOVAL AND 4124 Z BUMP ERROR MESSAGES ON THE AIA-900 INSTRUMENT. THE CUSTOMER STATED THAT THEY HAD PREVIOUSLY SHUT DOWN AND RESTARTED THE INSTRUMENT, BUT ERROR PERSISTED. 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), FOLLICLE STIMULATING HORMONE (FSH), LUTEINIZING HORMONE (LHII) AND PROGESTERONE (PROGIII) 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
    1025096 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1