BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 6950244 · Received October 13, 2017

    Report

    Report Number
    8031673-2017-00052
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    August 9, 2017
    Report Date
    July 8, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    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. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    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 15-AUG-2017 A FIELD SERVICE ENGINEER (FSE) PERFORMED HYBRID ARM ADJUSTMENT AND HYBRID ARM LEVEL MEASUREMENT PROCEDURE, WHICH RESOLVED THE ISSUE. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL (B)(4) FOUND ONE (1) SIMILAR COMPLAINT DURING THIS TIME PERIOD. THE AIA-2000 UNDER APPENDIX 3: FLAGS, STATES THAT A <L FLAG INDICATES THAT CALCULATION FAILED DUE TO ASSAY RESULT BEING UNDER ASSAY RANGE. IT IS IMPORTANT THAT USERS SHOULD NOT IGNORE THE FLAGS DISPLAYED WITH ASSAY RESULTS OF THE AIA-2000. APPENDIX 4: ERROR MESSAGES STATES THAT ERROR MESSAGE 4527 - PRETREATMENT-DETECTION TABLE ROTATION MOTOR OVERRUN OCCURS WHEN THE POSITIONING SENSOR ACTIVATES IMPROPERLY DURING ROTATING OF THE PRETREATMENT-DETECTION TABLE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN ALIGNMENT ISSUE WITH THE HYBRID ARM.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED ERROR MESSAGE 4527 - PRETREATMENT-DETECTION TABLE ROTATION MOTOR OVERRUN POSITIONING SENSOR AND HEARING AN UNUSUAL SOUND WITH THE AIA-2000 ANALYZER. ON 15-AUG-2017 A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE ISSUE. ON 14-SEP-2017 THROUGH A FOLLOW-UP WITH THE CUSTOMER, TOSOH BIOSCIENCE, INC., WAS NOTIFIED THAT ON (B)(6) 2017 THREE (3) PATIENT RESULTS WERE <L ON VITAMIN D THAT WERE WITHIN NORMAL RANGE UPON REPEAT. THE CUSTOMER WAS NOT ABLE TO PROVIDE SPECIFIC VALUES, WHETHER ANY OF THE RESULTS WERE REPORTED OUT OF THE LAB, AND IF ANY TREATMENT WAS ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727421 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1