BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8259450 · Received January 17, 2019

    Report

    Report Number
    8031673-2018-05435
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 28, 2018
    Report Date
    April 23, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. H.3. DEVICE EVALUATION BY MANUFACTURER: THE RETURNED PART COULD NOT BE LOCATED BY THE TOSOH INSTRUMENT SERVICE CENTER TECHNICIAN. PART WILL BE EVALUATED IF LATER FOUND IN THE FUTURE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    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 FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER'S SITE TO RESOLVE REPORTED EVENT. FSE CONFIRMED COMPLAINT BY VERIFYING SENSOR STATUS SCREEN AND ATTEMPTING A DAILY CHECK. FSE FOUND A FAULTY LEAD WIRE FOR LEVEL SENSOR AND REPLACED IT. FSE VALIDATED INSTRUMENT BY SUCCESSFULLY RUNNING A DAILY CHECK WITHOUT ANY ERRORS. 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 FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. . THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 7 - ERROR MESSAGES AND FLAGS, [3020] DILUENT LOW ERROR IS GENERATED WHEN THERE IS INSUFFICIENT DILUENT. THE SOLUTION IS FOR THE CUSTOMER TO REPLENISH THE DILUENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS PENDING INVESTIGATION COMPLETION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING 3020 DILUENT LOW ERROR MESSAGE WHEN ATTEMPTING TO PERFORM A DAILY CHECK RUN ON THE AIA-360 ANALYZER. THE CUSTOMER CONFIRMS THE DILUENT IS FULL. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO CLEAN THE CONTACTS ON THE DILUENT CAP AND SHUT THE ANALYZER DOWN. CUSTOMER THEN BROUGHT THE ANALYZER BACK UP AND TRIED TO REPEAT THE DAILY CHECK RUN, BUT ERROR PERSISTED. TSS THEN INSTRUCTED THE CUSTOMER TO PRIME THE DILUENT, BUT THE ANALYZER WILL NOT PRIME. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR INTACT PARATHYROID HORMONE (IPTH). 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
    48902 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1