BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7429873 · Received April 13, 2018

    Report

    Report Number
    8031673-2018-00300
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 15, 2018
    Report Date
    December 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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. THE G8, SERIAL NUMBER (B)(4), WAS INSTALLED ON 31-MAY-2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM INSTALLATION DATE THROUGH AWARE DATE. THERE WERE THREE (3) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. ON (B)(6) 2018, FSE AT CUSTOMER'S SITE, VERIFIED ERROR WAS CAUSED BY SAMPLE NOZZLE STUCK IN THE UPWARD POSITION. FSE UNSTUCK SAMPLE NOZZLE THEN CLEANED AND LUBRICATED TOP OF SAMPLE NOZZLE WHERE IT GOES THROUGH THE BRASS BUSHING TO ELIMINATE FURTHER STICKING PROBLEMS. FSE VERIFIED SAMPLE NOZZLE ALIGNMENTS, CLEANED TIP DISCARD CHUTE AND RAN DAILY MAINTENANCE AND QUALITY CONTROL. RUN COMPLETED SUCCESSFULLY WITHIN ACCEPTABLE RANGE. THE AIA 2000 INSTRUMENT IS FUNCTIONING WITHOUT ERRORS AFTER COMPLETING THE REPAIR. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 15FEB2017 THROUGH 15MAR2018. THERE WERE TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA 2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGES, STATES THE FOLLOWING. 4223: MAIN ARM Z-AXIS HOME OVERRUN ERROR IS GENERATED WHEN THE HOME SENSOR ACTIVATES IMPROPERLY AFTER MOVEMENT OF THE MAIN ARM Z-AXIS. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 4224: INTERFERENCE OF DISPENSING NOZZLE Z-AXIS OF MAIN ARM ERROR IS GENERATED WHEN THERE IS A POSSIBILITY THAT THE DISPENSING NOZZLE WAS INTERFERED WITH AN OBSTACLE SUCH AS CAP OF PRIMARY TUBE. THE MEASUREMENT RESULT WILL BE FLAGGED WITH THE SS FLAG. OR A COMMAND OR ADJUSTMENT VALUE (P05, 191-210) IS GIVEN FOR MOVEMENT BEYOND THE MAXIMUM MOVABLE DISTANCE OF THE MAIN ARM Z-AXIS IN THE MAINTENANCE OPERATION. SOLUTION : REMOVE ANY OBSTACLE SUCH AS CAP OF PRIMARY TUBE, IF ANY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO STUCK SAMPLE NOZZLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, CUSTOMER REPORTED GETTING ERROR MESSAGES 4223 "MAIN AXIS Z HOME OVERRUN" AND 4224 "MAIN ARM Z-AXIS LIMIT OVERRUN" DURING A RUN ON AIA 2000 INSTRUMENT. CUSTOMER ALSO STATED TIPS WERE NOT DISCARDING. THE CUSTOMER WAS DOWN AND UNABLE TO RUN. 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 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
    272837 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA 2000

    Patients

    Seq Age Sex Outcome Treatment
    1