BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7405371 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-00265
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 8, 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
    NY, 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. DEVICE EVALUATION BY MANUFACTURER: ON 09-MAR-2018, FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER'S SITE TO ADDRESS THE REPORTED EVENT. THE CUSTOMER INFORMED THE FSE THAT INTERMITTENTLY THE INSTRUMENT FAILED TO PROPERLY SENSE THE LEVEL OF SAMPLE, RESULTING IN THE SAMPLE NOZZLE BEING DRIVEN TO THE BOTTOM OF A TUBE CONTAINING SAMPLE, WITHOUT SENSING ANY SAMPLE. FSE INSPECTED INSTRUMENT AND OBSERVED TIP STUCK IN THE SERUM SEPARATOR GEL. FSE MEASURED RESISTANCE FROM EKI BOARD (LIQUID SURFACE DETECTION) TO TIP OF SAMPLE NOZZLE TO CHECK CONTINUITY, AND HE OBSERVED RESISTANCE TO BE 2OHMS INSTEAD OF 0OHMS. FSE REPLACED THE EKI BOARD SYSTEM AND SAMPLE NOZZLE. FSE CHECKED CLOG PARAMETER MAIN AND NOZZLE ALIGNMENT. CUSTOMER RAN CONTROLS AND REPORTED RESULTS WERE ALL IN ACCEPTABLE RANGE. THE AIA-2000 INSTRUMENT IS FUNCTIONING WITHOUT ANY ISSUES. THE AIA 2000LA, SERIAL NUMBER (B)(4), WAS INSTALLED ON (B)(6) 2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 SERVICE MANUAL UNDER CHAPTER 7 - ELECTRONICS, PROVIDES DETAILED INFORMATION ON OPERATIONAL PRINCIPLES AND CHECK POINTS FOR LIQUID SURFACE DETECTION AND CLOG DETECTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILED EKI BOARD AND SAMPLE NOZZLE CAUSED BY CLOGGING.

    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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. IN THE INITIAL MDR SUBMISSION INCORRECTLY LISTED THE INSTALLATION DATE OF THE INSTRUMENT AS 28-JUN-2017. IT SHOUD HAVE BEEN 06-JULY-2017.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED THAT 2 TIPS FELL OFF INTO SAMPLES AND WERE LODGED IN THE SERUM SEPARATOR ON THE AIA-2000 INSTRUMENT. THE CUSTOMER WOULD LIKE THE FIELD SERVICE ENGINEER (FSE) TO GO ONSITE AND CHECK THE SAMPLING ARM. A FIELD SERVICE ENGINEER (FSE) WILL BE DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR ALPHA-FETOPROTEIN (AFP). 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
    247751 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1