BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 6959933 · Received October 18, 2017

    Report

    Report Number
    8031673-2017-00057
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 20-SEP-2017 A FIELD SERVICE ENGINEER (FSE) THE HYBRID ARM SYRINGE, VERIFIED ALIGNMENT AND SETTING. THE FSE ALSO CLEANED THE BF WASH PROBES AREA AND TIPS. THE FSE THEN RAN QUALITY CONTROLS AND RAN PRECISION ON A PATIENT SAMPLE; ALL PASSED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017 WAS PERFORMED. TWO (2) SIMILAR COMPLAINTS WERE IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-2000 OPERATOR'S MANUAL RECOMMENDS CONTACTING TOSOH SERVICE CENTER OR THE LOCAL REPRESENTATIVE WHEN REQUIRING INSTRUMENT SERVICE. THE MOST PROBABLE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE HYBRID ARM SYRINGE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) -2017 A CUSTOMER REPORTING IMPRECISE VITAMIN B12 RESULTS ON PATIENT SAMPLES ON THE AIA-2000 ANALYZER. THE CUSTOMER REPORTED THAT VITAMIN B12 PATIENT RESULTS WERE HIGHER UPON REPEAT: INITIAL RUN: REPEAT RUN: PATIENT 1: 228 PG/ML, 516 PG/ML. PATIENT 2: 108 PG/ML, 335 PG/ML. PATIENT 3: 68 PG/ML ,199 PG/ML. PATIENT 4: 156 PG/M, 405 PG/ML. PATIENT 5: 133 PG/ML, 440 PG/ML. VITAMIN B12 ASSAY RANGE IS 50 - 2000 PG/ML. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738453 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1