BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7057847 · Received November 24, 2017

    Report

    Report Number
    8031673-2017-00125
    Event Type
    Malfunction
    Date Received
    November 24, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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. H.3. DEVICE EVALUATION BY MANUFACTURER: 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: ON (B)(4) 2017 A FIELD SERVICE ENGINEER (FSE) CONFIRMED WITH THE CUSTOMER OVER-THE-PHONE THE 3020 DILUENT LOW ERROR MESSAGE. THE FSE INSTRUCTED THE CUSTOMER TO INSPECT THE WIRES BETWEEN THE DILUENT BOTTLE AND PLUG. THE CUSTOMER FOUND A POSSIBLE WEAK AREA IN THE LEVEL SENSOR LEAD WIRE. THE FSE ORDERED A REPLACEMENT LEVEL SENSOR LEAD WIRE. ON (B)(4) 2017 THE FSE WALKED THE CUSTOMER TO REPLACE THE LEVEL SENSOR LEAD WIRE. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE CUSTOMER RAN DILUENT AND WASH PRIMES WITHOUT ANY FURTHER ERRORS. THE AIA-360 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE AIA-360 INSTRUMENT, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 7, LIST OF ERROR MESSAGES, STATES THE 3020 DILUENT LOW ERROR MESSAGE IS GENERATED WHEN THE DILUENT IS RUNNING LOW. THE OPERATOR IS INSTRUCTED TO REPLENISH THE DILUENT. CHAPTER 2, INSTALLATION, PROVIDES STEP-BY-STEP INSTRUCTIONS ON CONNECTING THE LEVEL SENSOR LEAD WIRES. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A DEFECTIVE LEVEL SENSOR LEAD WIRE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 3020 DILUENT LOW ERROR MESSAGE WHILE RUNNING PATIENT SAMPLES ON INTACT PARATHYROID HORMONE (IPTH) WITH THE AIA-360. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON IPTH. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4) PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836800 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1