BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7649466 · Received June 29, 2018

    Report

    Report Number
    8031673-2018-00585
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: FIELD SERVICE ENGINEERING CONTACTED THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. THE CUSTOMER DECLINED SERVICE ON THE INSTRUMENT. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS FOR AIA-360 INSTRUMENT WITH SERIAL NUMBER (B)(4) AND FOR PARATHYROID HORMONE (PTH) LOT 15205 WAS CONDUCTED FROM (B)(4) 2017 THROUGH AWARE DATE (B)(4) 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: 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 COULD NOT BE DETERMINED. THE CUSTOMER DECLINED SERVICE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY WERE GETTING <L FLAGS ON PARATHYROID HORMONE (PTH) QUALITY CONTROL (QC) AND PATIENT SAMPLES WHILE RUNNING THE AIA-360 INSTRUMENT. THE CUSTOMER REPEATED THE QC WITH FRESH SUBSTRATE AND PERFORMED THE BF PROBE MAINTENANCE. THE PTH LEVEL 1 QC LOT 5205 WAS CALIBRATED SEVERAL WEEKS PRIOR WITH A RESULT OF 0.099 PG/ML. THE CUSTOMER RAN TOSOH QC 20 DAYS AFTER THE CALIBRATION WITH RESULTS FOR LEVEL 1= 41.1 AND LEVEL 2= 704.4 WITH ACCEPTABLE RESULTS. PTH WAS CALIBRATED AGAIN WITH LEVEL 1 LOT 15205 RESULT OF 0.09 PG/ML. THE CUSTOMER REPEATED THE QC WITH FRESH SUBSTRATE AND AFTER CLEANING THE BF PROBE. THE CUSTOMER REPORTED THE SPECIMEN RATES ON THE PRINTOUT AND ALL OF THE QC AND PATIENT SAMPLES RATES BEFORE AND AFTER THE SUBSTRATE HAVE BEEN -0.0034 OR 0.0013, WITH A VERY LOW RATE. THE CUSTOMER WAS CONCERNED ABOUT THE SAMPLING. THE SAMPLE PROBE WAS INTACT. FIELD SERVICE ENGINEERING (FSE) WAS DISPATCHED WHICH RESULTED IN A DELAY OF PARATHYROID HORMONE (PTH) PATIENT RESULTS. 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
    494825 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1