BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7298537 · Received February 26, 2018

    Report

    Report Number
    8031673-2018-00132
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 26, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 (B)(6) 2018, A FIELD SERVICE ENGINEER (FSE) CHECKED THE SAMPLE NOZZLE ASSEMBLY FOR CLOGS, BUT NONE WERE FOUND. THE FSE RAN SEVERAL PATIENT SAMPLES WITH NO ISSUES. THE CUSTOMER CONFIRMED THAT THE SS AND SP FLAGS WERE PRESENT DURING CALIBRATION ON IPTH. THE FSE CONFIRMED WITH THE CUSTOMER THAT THEY WERE ALWAYS USING TUBES FOR PATIENT SAMPLES AND CALIBRATION. THE FSE CHECKED AND ADJUSTED THE SAMPLE TUBE BOTTOM. THE FSE THEN RAN IPTH CALIBRATION WITH NO FLAGS. THE AIA-360 INSTRUMENT WAS FUNCTIONING WITHOUT ANY ISSUES; NO FURTHER ACTION WAS REQUIRED BY THE FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-2: LIST OF FLAGS, STATES THE FOLLOWING: 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". SS: THE ASSAY WAS CANCELLED BECAUSE OF INSUFFICIENT SAMPLE. IF THIS FLAG APPEARS WHEN THERE IS AN ENOUGH SAMPLE, EITHER THE SAMPLE NOZZLE OR THE SAMPLE DETECTION SENSOR MAY BE FAULTY. IF THIS PROBLEM OCCURS FREQUENTLY, CONTACT THE SERVICE DEPARTMENT. SP: THE WASTE BOTTLE HAS BECOME FULL. DISCARD THE WASTE LIQUID AND REPEAT ASSAY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE SAMPLE TUBE BOTTOM NEEDING ADJUSTMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING INSUFFICIENT SAMPLE (SS) AND WASTE LIQUID FULL (SP) FLAGS DURING CALIBRATION ON THE AIA-360 INSTRUMENT. THE CUSTOMER REPORTED THAT THE CALIBRATOR CUPS WERE FULL AND PLACEMENT ON THE INSTRUMENT WAS CORRECT. THE CUSTOMER REQUESTED SERVICE IN ORDER TO FURTHER INVESTIGATE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR INTACT PARATHYROID HORMONE (IPTH) AND CARDIAC TROPONIN I (CTNL2). THERE IS 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
    141176 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1