BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-1800

    MDR report key: 7375764 · Received March 27, 2018

    Report

    Report Number
    8031673-2018-04131
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    June 25, 2015
    Report Date
    March 27, 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

    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 25-JUN-2015, A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT WHERE THE CUSTOMER INFORMED THAT THEY HAD BHCG FAILURE ONCE IN 2013. AT THAT TIME WAS RUNNING PROFICIENCY TEST ON TOSOH AND ON IMMULITE. CUSTOMER WAS TOLD THERE MIGHT BE CROSS CONTAMINATION SO NOW ONLY USE TOSOH. QA PASSED THIS EVENT WITH NO ISSUES. N=20 CV 2.0% RECENTLY HAD PREVENTIVE MAINTENANCE PERFORMED. NO FURTHER ACTION REQUIRED. THE PROBABLE CAUSE OF THE EVENT WAS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED BHCG PROFICIENCY TESTING API SECOND EVENT WITH THEIR AIA-1800 ANALYZER. LOT 25 QC OMNIMUNE L1-7 MEAN 7.36 L2= 45 MEAN 44.4. RESULTS FROM DAY PT AS RUN CH 06 , 2529 , 1421-2370 . RERAN AND GOT 2004 SO WAS IN RANGE UPON RERUN; CH 07 , 1599 ,1156-1884; CH 08, 229 ,198-259; CH 09 , 2623 , 1824-3249; CH 10 , 1153 , 868-1303. THE CUSTOMER IS UNABLE TO RUN BCHG PATIENT SAMPLES. A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BCHG 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
    217192 AIA-1800 AIA-1800 KHO TOSOH CORPORATION AIA-1800

    Patients

    Seq Age Sex Outcome Treatment
    1