BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7545961 · Received May 25, 2018

    Report

    Report Number
    8031673-2018-00446
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 30, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4) WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, 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. 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

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE FOUND THE CUP SORTER WAS NOT READING THE TEST CUPS. FSE ADJUSTED THE SORTER Y-AXIS AND VERIFIED PROPER BAR CODE READER FUNCTION. FSE THEN RAN TESTS FOR SYSTEM OPERATION AND CONCLUDED THE AIA-2000 INSTRUMENT FUNCTIONS AS INTENDED. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. THE AIA-2000 INSTRUMENT, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2018. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM (B)(6) 2018 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL, IN CHAPTER 9 - MAINTENANCE, SECTION 9.6 STATES: WHEN IDLE FOR LONG PERIODS WHEN THE SYSTEM IS LEFT IDLE FOR EXTENDED PERIODS, IT IS RECOMMENDED THAT WASH SOLUTION AND DILUENT OF SOLUTION LINES ARE DISCARDED AND PRIMED BY DISTILLED WATER. ALSO MAKE SURE TO EMPTY THE WASTE TANK AND THE WASTE BOX OF CUPS AND TIPS. PRIME THE SUBSTRATE LINES WITH THE SUBSTRATE REPLACEMENT SOLUTION (70 % ETHANOL) AND MAKE SURE THAT THE MAIN POWER SWITCH HAS BEEN TURNED OFF. SECTION 9.7 ADDED "CLEAN THE SUBSTRATE LINES FIRST WITH NITRIC ACID, THEN WITH THE SUBSTRATE REPLACEMENT SOLUTION (70 % ETHANOL) BEFORE SWITCHING TO THE SUBSTRATE. FOR DESCRIPTION OF PROCEDURES, REFER TO "CHAPTER 9: 9.1.1 CLEANING THE SUBSTRATE LINES." UNDER SAFETY PRECAUTIONS CHAPTER: AT SYSTEM SHUTDOWN, REPLACE THE SUBSTRATE SOLUTION REMAINING IN THE SUBSTRATE LINE WITH SUBSTRATE REPLACEMENT SOLUTION (70% ETHANOL). IF THE SUBSTRATE SOLUTION REMAINS IN THE SUBSTRATE LINE FOR A LONG TIME, IT MAY PRECIPITATE. PRECIPITATION IN THE SUBSTRATE LINE MAY CLOG THE SUBSTRATE LINE. REPLACEMENT OF THE SUBSTRATE SOLUTION WITH DISTILLED WATER MAY CAUSE CONTAMINATION OF THE SUBSTRATE LINE AND RAISE THE SUBSTRATE BACKGROUND. MAKE SURE TO USE THE SUBSTRATE REPLACEMENT SOLUTION (70% ETHANOL) AT SYSTEM SHUTDOWN. IN ADDITION, IT IS RECOMMENDED THAT THE SUBSTRATE BE REFRIGERATED. THE MOST PROBABLE CAUSE WAS DUE TO CUP SORTER READER NEEDED ADJUSTMENT.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS FOLLOW-UP #2 IS FOR A CORRECTION IN THE PREVIOUSLY SUBMITTED FOLLOW-UP #1 WHERE THE DATES IN THESE SECTIONS WERE INCORRECT. (B)(4) PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING HIGH SUBSTRATE BACKGROUND UPON STARTUP OF THE AIA-2000 INSTRUMENT. CUSTOMER NOTED THE INSTRUMENT WAS LEFT ON WITH THE SUBSTRATE STILL IN THE ANALYZER FOR SEVERAL DAYS. DESPITE REPLACING THE SUBSTRATE WITH A NEW ONE, PRIMING, AND RAN TWO DAILY CHECKS, THE ISSUE PERSISTED. THE CUSTOMER IS UNABLE TO RUN INTACT PARATHYROID HORMONE (IPTH) ON PATIENT SAMPLES. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH. THERE WAS 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
    387753 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1