BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7563621 · Received June 1, 2018

    Report

    Report Number
    8031673-2018-00508
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K0971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE REVIEWED THE CALIBRATION THAT HAD BEEN PERFORMED ON (B)(6) 2018 AND FOUND THE RATES FOR THE DIFFERENT CALIBRATION CURVE TO BE INCONSISTENT. FSE REPLACED THE NOZZLE ASSEMBLY, REPEATED CALIBRATION, RAN QUALITY CONTROL (QC), AND PERFORMED A SOFTWARE UPGRADE TO VERSION 1.36S. RATES FOR EACH POINT HAD GOOD PRECISION AND QC RESULTS WERE WITHIN RANGE. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE THREE SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR IPTH LOT HZ15204, IPTH CALIBRATOR LOT HZ35262 AND SUBSTRATE LOT 1960043 WAS PERFORMED. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-360 OPERATOR'S MANUAL REVISION 10, UNDER CHAPTER 4 & 5- SYSTEM STARTUP AND CALIBRATION WERE REVIEWED. CHAPTER 4-2 SYSTEM STARTUP: GENERATING CALIBRATION CURVES PREPARE CALIBRATOR AND REAGENT CUPS. MEASURING CALIBRATORS IS NECESSARY WHEN GENERATING CALIBRATION CURVES. BEGIN BY COMPILING AN APPROPRIATE CALIBRATION PROGRAM, THEN PREPARE CALIBRATORS AND REAGENT CUPS AND PERFORM MEASURING OPERATIONS ACCORDINGLY. CHAPTER 5: GENERATING CALIBRATION CURVES- THE 2.1 CALIBRATION REVIEW. THE FIRST ASSAY RESULT IS OUTPUT APPROXIMATELY 20 MINUTES AFTER THE ASSAY OPERATION BEGINS, RESULT REPORTS APPEAR EVERY 100 SEC THEREAFTER. REVIEW AND CALCULATIONS USING THE CALIBRATION DATA SHOULD BE CONDUCTED WHEN CALIBRATION IS COMPLETE. CALIBRATION DATA CAN BE REVIEWED USING THE CALIB REVIEW SCREEN. THE SYSTEM IS DESIGNED SO THAT ALL UNFLAGGED ASSAY RESULTS THAT APPEAR WHEN THE SCREEN IS DISPLAYED ARE ACCEPTED. IN ORDER TO DELETE DATA INAPPROPRIATE FOR THE CALIBRATION CALCULATIONS, USE TO MOVE THE CURSOR TO THE INAPPROPRIATE VALUE AND PRESS TO REJECT. TO ACCEPT THE REJECTED DATA ITEM, SIMPLY PRESS TO TOGGLE. THE 2.2 VERIFYING CALIBRATION CURVES THE CALIBRATION CURVES ARE VERIFIED ONCE CALIBRATION RESULTS HAVE BEEN REVIEWED. NOTE THAT ASSAY DATA CANNOT BE CHANGED OR RECALCULATED ONCE VERIFICATION HAS BEEN PERFORMED. THE MAXIMUM NUMBER OF LOTS VERIFIABLE PER ANALYTE IS TWO. THE SAME LOT CANNOT BE VERIFIED. THE AIA-360 SERVICE MANUAL REVISION 1; UNDER CHAPTER 3-11- REPLACING PERMANENT NOZZLE WAS REVIEWED. THE 3.11.2 REPLACING PERMANENT NOZZLE: REMOVE THE SCREWS SECURING THE NOZZLE (BE CAREFUL NOT TO DROP SCREWS OR RETAINING PLATE). REMOVE THE NOZZLE FROM ABOVE AND LOOSEN THE FLARE FITTING ON THE PRESSURE SENSOR UNIT AND REMOVE. PREPARE A REPLACEMENT NOZZLE AND INSTALL USING THE REMOVAL PROCEDURES IN REVERSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE NOZZLE ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED IMPRECISION WITH INTACT PARATHYROID HORMONE (IPTH) WHEN CALIBRATING A NEW LOT WITH THEIR AIA-360 ANALYZER. THE CUSTOMER QUESTIONED THE RATE SO SHE RECALIBRATED A SECOND TIME. CALIBRATION RATES THE SECOND TIME WERE 0.117, 0.116, 0.115/0.52, 0.64/0.35/7.2, 6.8, 6.3/SS/27.1, 27.7, 27/85.1, 82.9, AND 87 USING PTH LOT HZ15204, CALIBRATOR LOT HZ35262, & SUBSTRATE LOT 1960043. THE CUSTOMER HAD REPORTEDLY EXPERIENCED A SIMILAR ISSUE IN MARCH 2018 AND IT HAD BEEN RESOLVED BY DECONTAMINATION. AS A RESULT, TECHNICAL SUPPORT (TS) ADVISED HER TO DECONTAMINATE THE DEVICE AGAIN AND RETRY CALIBRATION. THE FOLLOWING DAY THE CUSTOMER CALIBRATED WITH IPTH LOT I315209, CALIBRATOR LOT I235263, AND SUBSTRATE LOT IX 60053 THAT HAD BEEN SUPPLIED BY TS. RESULTING CALIBRATION RATES WERE 0.11, 0.10, 0.13/0.71, 1.00, 0.74/ 2.45, 2.98, 2.14/ 11.8, 8.5, 12.3/ 35.6, 34.6, 48.5/ 91.2, 118.6, AND 132.3. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH. THERE WAS 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
    402435 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1