BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7384363 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-04149
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    June 19, 2017
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10.ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA 2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3.DEVICE BY MANUFACTURER: ON 19-JUN-2017, A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT WHERE THE CUSTOMER INFORMED THAT THEY BMG FAILURES. CUSTOMER REPORTS BMG PT FAILURE API 1ST EVENT 2017 BMG FAILED ALL THREE LEVELS TMI-01= 0.965 LOW RANGE 0.968-1.527 TOSOH - 1.295 TMI-02= 4.80 HIGH RANGE 3.288-4.671 TOSOH = 3.939 TMI-03= 0.41HIGH RANGE 0.237-0.383 TOSOH = 0.312 FROZEN API SAMPLES REPEAT 6-19-17 TMI-01= 1.3 IN NEAR THE MEAN TMI-02= 4.5 IN BUT AT THE UPPER END TMI-03= 0.37 IN BUT AT THE UPPER END RAN AN N=10 OF A WHOLE BLOOD SAMPLE 3.6284 3.4377 3.4379 3.5268 3.5895 3.4815 3.5603 3.5001 3.4113 3.4169 OBS MEAN = 3.49904 SD = 0.074579 PRECISION = 2.2% CONTROLS ARE IN AND CALIBRATION CURVE WAS AS EXPECTED FROM PREVIOUS CURVE TS DID ASK FOR CONTROL AND CAL DATA AND ADVISED HER TO FILL OUT THE API REPORT NO FURTHER ACTION REQUIRED. THE PROBABLE CAUSE OF THE EVENT WAS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED BMG API PROFICIENCY TESTING (PT) FAILURE WITH THEIR AIA-900 ANALYZER. THE CUSTOMER IS UNABLE TO RUN BMG PATIENT SAMPLES. A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BMG 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
    225573 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1