BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7602886 · Received June 14, 2018

    Report

    Report Number
    3005529799-2018-00530
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 14, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    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. DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS FOR AIA-360 INSTRUMENT WITH SERIAL (B)(4) AND FOR ESTRADIOL (E2) LOT H8129B6 WAS CONDUCTED FROM 23-APR-2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 7, SECTION 7-2 , ERROR MESSAGES AND FLAGS STATES THE FOLLOWING: SECTION 7.2: LIST OF FLAGS: A FLAG IS ATTACHED TO AN ASSAY RESULT AS APPROPRIATE: AN ERROR FLAG IF AN ASSAY DOES NOT COMPLETE NORMALLY BECAUSE OF A PROBLEM OR A USER FLAG (NORMAL OR ABNORMAL VALUE) TO ENABLE THE USER TO DISCRIMINATE AN ASSAY RESULT. WHEN AN ERROR FLAG IS ATTACHED, THE ASSAY RESULT MAY OR MAY NOT BE AVAILABLE DEPENDING ON THE ERROR. WHEN AN ERROR FLAG IS NOT ATTACHED, THE RESULT OF A NORMALLY FINISHED ASSAY IS AVAILABLE. IF NO ASSAY RESULT IS AVAILABLE DUE TO AN ERROR, TAKE THE APPROPRIATE ACTION ACCORDING TO SECTION 2.1 "FLAG LISTS" AND SECTION 2.2 "DETAILED MEANINGS OF FLAGS AND ACTION". A <L FLAG INDICATES THAT THE ASSAY RESULT WAS NOT ACCEPTED BECAUSE IT LIES BELOW THE CALIBRATION AREA. CHAPTER 10-3 MONTHLY MAINTENANCE PROCEDURES STATES THE FOLLOWING: SECTION 3.1 UPDATING CALIBRATION CURVES: THE LENGTH OF VALIDITY OF THE CALIBRATION CURVE VARIES ACCORDING TO THE ITEM; HOWEVER, MOST REMAIN VALID FOR 90 DAYS. ASSAY RESULTS WILL BE FLAGGED WITH THE CV FLAG WHEN A CALIBRATION CURVE HAS EXPIRED. UPDATE CALIBRATION CURVES AS NECESSARY. THE MOST PROBABLE CAUSE OF THE <L FLAG WAS DUE TO EXPIRATION OF THE E2(ESTRADIOL) CALIBRATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY WERE GETTING <L FLAGS ON ESTRADIOL (E2) ON TWO PATIENT RESULTS WHILE RUNNING THE AIA-360 INSTRUMENT. THE CUSTOMER ALSO RAN A RANDOM EMPLOYEE'S BLOOD AND STILL RESULTED IN A <L FLAG. THE CUSTOMER WAS USING E2 TEST CUP LOT H8129B6 AND BIORAD (BR) QUALITY CONTROL (QC) WAS 208.3 (RANGE 185-344) AND L1 RESULT WAS 477.6 (RANGE 406-754.6). THE CUSTOMER REPORTED THAT THE E2 WAS LAST CALIBRATED THREE MONTHS PRIOR BUT WAS ALREADY CALIBRATING THE E2 WHEN THE CALL WAS PLACED SINCE THE CALIBRATION CURVE EXPIRED THE DAY BEFORE. AFTER RUNNING CALIBRATION AND QC, THE CUSTOMER REPORTED THAT THE PATIENT RESULTS AND QC WERE IN RANGE. THE CUSTOMER DECLINED TO GIVE THE ACTUAL PATIENT AND QC RESULTS. THE EVENT RESULTED IN DELAYED REPORTING OF ESTRADIOL (E2) PATIENT RESULTS DUE TO A CALIBRATION ISSUE. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445767 AIA-360 AIA-360 KHO TOSOH BIOSCIENCE, INC. AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1