BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7403816 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-03738
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    October 5, 2015
    Report Date
    April 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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. CUSTOMER REPORTED FIRST RUN BHCG 37, E2 153, FSH 34, PROG <L; SECOND RUN BHCG <L, E2 158, FSH 5.7, PROG <L. RERAN BHCG AND WAS 39.4. CUSTOMER ASKED FOR PRECISION ON QC AND ON THIS SAMPLE. QC WAS ALL IN RANGE. RAN AGAIN AND SAME. NO ERRORS ON THE PRINTOUTS. WASH AND DILUTION DID NOT RUN LOW DURING THE RUN - DIDN'T ADD TO EITHER DURING THE RUN. THEY DID GET A Y AXIS ERROR THAT MORNING. DID FIND SOME DROPPED CUPS. THEY HAVE A SECOND 2000 FOR BACKUP BUT NOT SURE THERE IS A CALIBRATION CURVE FOR THIS LOT #37. THEY REPORTED THEY WILL CHECK. SENDING OUT SAMPLES FOR CONFIRMATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS UNDETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2015 THE CUSTOMER REPORTED PATIENT RESULT DISCREPANCIES WITH THEIR AIA-2000 ANALYZER. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247132 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1