BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH AIA-900

    MDR report key: 6767486 · Received August 4, 2017

    Report

    Report Number
    8031673-2017-00004
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    April 12, 2017
    Report Date
    June 10, 2019
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 13-APR-2017 A FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO FURTHER EVALUATE THE REPORTED ISSUE. THE FSE CHECKED THE ALIGNMENTS OF THE BARCODE READER, CUP AND TUBE DETECTION, AND LOADER POSITIONING. THE INSTRUMENT READ ALL BARCODES AND IDENTIFIED ANY ARRANGEMENT OF CUPS/TUBES/TEST CUPS HOLDERS ACCURATELY. THE FSE COULD NOT REPLICATE THE REPORTED EVENT. THE CUSTOMER RAN QUALITY CONTROLS AND 20 SAMPLES WITHOUT ANY ERRORS. ON 19-APR-2017 A FIELD SERVICE ENGINEER WENT ONSITE TO GATHER LOGS AND SPECIMEN TUBES FOR FURTHER INVESTIGATION. AFTER EXTENSIVE EXAM OF THE LOGS PROVIDED BY THE CUSTOMER, THE MOST LIKELY CONCLUSION WAS AN OPERATOR LOADED THE SAMPLES INCORRECTLY. FURTHER INVESTIGATION INTO THIS ISSUE IS BEING PERFORMED. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013..

    Additional Manufacturer Narrative · 0

    A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 10895506 FROM 12-MAR-2016 THROUGH AWARE DATE 12-APR-2017. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 8, SYSTEM OPERATIONS, PROVIDES INSTRUCTIONS ON PROPER SAMPLE LOADING. NO FURTHER INVESTIGATION WAS PERFORMED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE OPERATOR LOADING THE SAMPLES INCORRECTLY. CORRECTED DATA: FOR CORRECTED DATA, PLEASE REFER TO DEVICE MANUFACTURE DATE. 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.

    Additional Manufacturer Narrative · 0

    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

    THE CUSTOMER REPORTED THAT ON (B)(6) 2017 TWO PATIENT SAMPLES WERE RUN, AND ALTHOUGH THERE WERE NO ERRORS IN THE LOG, THE INSTRUMENT REPORTED THE TEST RESULTS FOR THE FIRST PATIENT ALONG WITH THE TEST RESULTS FOR THE SECOND PATIENT UNDER THE SAME BARCODE AND IT SEEMED AS THOUGH THE INSTRUMENT HAD SKIPPED THAT PATIENT - NO PATIENT RESULTS GENERATED. THE CUSTOMER ADDED THAT IT SEEMED AS THOUGH THE AIA-900 COULD NOT READ THE BARCODE AND KEPT GOING BACK TO THE PREVIOUS READABLE SAMPLE CUP TO TEST UNTIL IT COULD READ THE NEXT SAMPLE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549645 TOSOH AIA-900 AIA-900 KHO TOSOH HI-TEC AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1