BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7387703 · Received March 31, 2018

    Report

    Report Number
    8031673-2018-04731
    Event Type
    Malfunction
    Date Received
    March 31, 2018
    Date of Event
    November 16, 2016
    Report Date
    March 31, 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

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. 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. H.3. DEVICE EVALUATION BY MANUFACTURER: ON 16-NOV-2016, AN TECHNICAL SUPPORT SPECIALIST (TSS) CONDUCTED FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. THE CUSTOMER ASKED WHY THE QC WAS MUCH LOWER WHEN REPEATED. TSS DISCUSSED ABOUT RUNNING QC AT ROOM TEMPERATURE. TSS ALSO DISCUSSED ESTABLISHING QC RANGES AND ADVISED THE CUSTOMER TO RECALIBRATE AFTER PERFORMING THE DECONTAMINATION PROCEDURE AND WASH PROBE MAINTENANCE. TSS SUGGESTED THE CUSTOMER RUN A PRECISION STUDY TO VERIFY SAMPLING. ON 16 NOVEMBER 2016, AN FSE CONDUCTED FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. THE FSE PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND ORDERED A NEEDLE FOR THE CUSTOMER TO REPLACE. THE CUSTOMER REPLACED THE NEEDLE AND RAN CALIBRATION, QC, AND PERCISION AND DID NOT REPORT ANY FURTHER CONCERNS. THE AIA-360 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE NEEDLE.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED LOWER QUALITY CONTROL (QC) RESULTS WHEN REPEATED WITH THEIR AIA-360 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING CTNI 2 AND IPTH 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
    230294 AIA-360 AIA-360, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1