BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7410368 · Received April 9, 2018

    Report

    Report Number
    8031673-2018-05042
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    January 26, 2016
    Report Date
    April 9, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 26-JAN-2016 A TECHNICAL SUPPORT SPECIALIST (TSS) ATTEMPTED TO TROUBLESHOOT THE REPORTED ISSUE OVER THE PHONE WITH THE CUSTOMER. THE TSS REQUESTED THE CUSTOMER SEND IN TO QA, HOWEVER, THE CUSTOMER NO LONGER HAD THE SAMPLE. THE CUSTOMER ALSO REPORTED ALL PATIENTS ARE ON DIFFERENT PROTOCOLS. THE TSS ASKED IF ALL WERE RUN ON THE SAME LOT AND ASKED THE CUSTOMER TO RUN A PRECISION ON L1 WHICH IS CLOSE TO ASSAY LOW. THE CUSTOMER EMAILED PM AND TSM FOR INPUT. TSS ASKED THE CUSTOMER IF THE LAB TESTED FOR HETEROPHIL ANTIBODIES DUE TO POSSIBLE INTERFERENCE DUE TO RABBIT ANTIBODIES (HARA). ON 24- FEB-2016 TSS REQUESTED THE LAB PERFORM A DILUTION STUDY TO TEST FOR ANY KIND OF INTERFERENCE- PROCEDURE SENT. ON 04-APR-2016 TSS ASKED THE CUSTOMER TO CONSIDER DRAWING NA HEP ON PATIENTS TO SEE IF THEY CORRELATED WITHOUT DILUTIONS. PM AND QA TO SEND INFORMATION. NO FURTHER INVESTIGATION AS INSUFFICIENT DATA TO DETERMINE. NO FURTHER ACTION REQUIRED BY TSS/FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS UNKNOWN. TOSOH BIOSCIENCE, INC. IS SUBMITTNG ON BEHALF OF THE FOREIGN MANUFACTURER TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT ISBEING 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.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER DISCREPANT PATIENT RESULTS FOR E2 WITH THE AIA-360 ANALYZER. THE CUSTOMER IS UNABLE TO RUN E2 PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING E2 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
    250022 AIA-360 AIA-360 LCP TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1