BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 6965981 · Received October 20, 2017

    Report

    Report Number
    8031673-2017-00060
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 20, 2017
    Report Date
    December 28, 2017
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ON 22-SEP-2017 A FIELD SERVICE ENGINEER (FSE) PERFORMED DISPENSE 10 AND SUCTION 10 DIAGNOSTIC TESTING, VERIFIED THAT THE DISPENSE AND ASPIRATION OF THE WASH WAS CONSISTENT; THE BF PROBE POSITIONING WAS VERIFIED TO BE CORRECT AS WELL. THE FSE CHECKED ALL PIPETTING POSITIONS, TEMPERATURE WAS IN RANGE, PERFORMED A LIQUID LEVEL SENSE TEST, AND ADJUSTED THE CUP AND TUBE PARAMETERS AS WELL. THE FSE PERFORMED A PRECISION RUN 10 TIMES ON THE AIA-360, WHICH OBTAINED ACCEPTABLE RESULTS. THE FSE RAN QUALITY CONTROLS, WHICH WERE ALSO WITHIN ACCEPTABLE RANGE. THE FSE WAS NOT ABLE TO DETERMINE THE CAUSE OF THE REPORTED IMPRECISE RESULTS. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FROM 20-AUG-2016 THROUGH 20-SEP-2017 WAS PERFORMED. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 4 - 1. PRIOR TO COMMENCING OPERATION, STATES: APPLICABLE SPECIMEN TYPE FOR THE AIA-360 IS INDICATED ON THE INSERT SHEET PROVIDED WITH REAGENTS FOR EACH ANALYTE. USERS ARE ASKED TO AVOID ASSAYING THE FOLLOWING TYPES OF SPECIMENS, AS THEY CAN AFFECT SYSTEM OPERATION. · SPECIMENS THAT HAVE A TENDENCY TO CLOT DURING THE ASSAY PROCESS. · SPECIMENS CONTAINING SOLID PARTICLES THAT TEND TO FORM OCCLUSIONS DURING DISPENSE OPERATIONS. THE CAUSE OF THE REPORTED IMPRECISE ESTRADIOL RESULT COULD NOT BE DETERMINED. THE AIA-360 ANALYZER IS PERFORMING WITHIN SPECIFICATIONS.

    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".

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED A PATIENT SAMPLE RAN ON (B)(6) 2017 ON ESTRADIOL OBTAINED A RESULT OF 1364 PG/ML, WHICH UPON REPEAT TWO DAYS LATER WAS 255 PG/ML (ASSAY RANGE 25 - 3000 PG/ML) ON THE AIA-360 ANALYZER. THE CUSTOMER REPORTED QUALITY CONTROL LEVEY JENNINGS AND ORIGINAL PRINTOUT WERE NOT SAVED; THEREFORE, NOT AVAILABLE FOR FURTHER EVALUATION BY TOSOH BIOSCIENCE, INC. THE CUSTOMER STATED THAT SAMPLES ARE DRAWN IN SERUM SEPARATED TUBES, SIT FOR 20-30 MINUTES TO CLOT AND SPUN FOR 15 MINUTES. THE ORIGINAL SERUM SEPARATED TUBE IS THEN PLACED ON THE AIA-360 ANALYZER FOR TESTING. THE CUSTOMER WAS ADVISED TO LET THE SAMPLE SIT LONGER FOR 15-45 MINUTES. THE CUSTOMER REPORTED THAT NO SS OR SC FLAGS WERE SEEN ON THE SAMPLE. THE CUSTOMER DOES NOT BELIEVE THAT THE ISSUE IS DUE TO DRUG INTERFERENCE AS THE PATIENT IS ON FERTILITY DRUG. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE ISSUE. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746282 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1