BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7467442 · Received April 26, 2018

    Report

    Report Number
    8031673-2018-00363
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 2, 2018
    Report Date
    May 17, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. CORRECTED DATA: THESE SECTIONS WERE INCORRECT IN THE INITIAL MDR AND HAVE BEEN CORRECTED TO THE FOLLOWING: DATE OF EVENT: 02-APR-2018. DATE USER FACILITY/IMPORTER BECAME AWARE OF EVENT: 02-APR-2018. DATE RECEIVED BY MANUFACTURER: 02-APR-2018. IT WAS REPORTED IN THE INITIAL MDR THAT THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 29-MAR-2018. HOWEVER, THE CORRECT DISPATCH DATE WAS 02-APR-2018. THE 13 MONTH REVIEW IN THE INITIAL MDR WAS CORRECTED TO STATE: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOR 02-MAR-2017 THROUGH AWARE DATE 02-APR-2018 FOR SIMILAR COMPLAINTS WERE PERFORMED. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD.

    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) 2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE OBSERVED AND CONFIRMED THE REPORTED ERRORS 2101 AND 4253 FROM THE DEVICE LOG. FSE CONDUCTED TROUBLESHOOTING BY RUNNING CUP TRANSFER MACRO TEST AND PERFORMING HYBRID ARM TIP ATTACH AND DETACH TO WATCH OPERATION. FSE OBSERVED THE WASH PROBE #4 WAS NOT HOMING AND IDENTIFIED THE SOURCE TO BE FROM THE SLAVE PCB BOARD 5-6. FSE REPLACED THE SLAVE PCB BOARD, REALIGNED THE HYBRID ARM TIP POSITION, AND VALIDATED PROPER OPERATION BY CUP TRANSFER MACRO. FSE THEN RAN QUALITY CONTROLS (QC) AND ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE AIA-2000 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AND THE REPORTED ERRORS CLEARED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A (B)(4) COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOR (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018 FOR SIMILAR COMPLAINTS WERE PERFORMED. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER CHAPTER 6: SYSTEM OPERATION AND APPENDIX 4: ERROR MESSAGES STATE: ERROR 2101 IS TIP DETACHMENT FAILURE BY HYBRID ARM. THIS MESSAGE IS GENERATED WHEN A TIP WAS DETECTED BY TIP DETACHMENT CHECK. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED MECHANICAL FAILURE (MF FLAG). THE SOLUTION IS FOR THE CUSTOMER TO CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. ERROR 4253 IS HYBRID ARM Z-AXIS HOME OVERRUNS. THE MESSAGE IS GENERATED WHEN THE HOME SENSOR ACTIVATED IMPROPERLY AFTER MOVEMENT OF THE HYBRID ARM Z-AXIS. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED MECHANICAL FAILURE (MF FLAG). THE SOLUTION IS FOR THE CUSTOMER TO CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO DEFECTIVE SLAVE 5-6 PCB BOARD.

    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. CORRECTED DATA: APPROXIMATE AGE OF DEVICE: 8 YEARS.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING ERRORS 2101 TIP DETACHMENT FAILURE BY HYBRID ARM AND 4253 HYBRID ARM Z-AXIS HOME OVERRUNS ON THE AIA-2000 INSTRUMENT. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON ALPHA-FETOPROTEIN (AFP). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR 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
    306210 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1