BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7376721 · Received March 28, 2018

    Report

    Report Number
    8031673-2018-04712
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    November 16, 2015
    Report Date
    March 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: THE FIELD SERVICE ENGINEER WAS DISPATCHED ON 16 NOVEMBER 2015. THE FSE CHECKED THE TIP TOP POSITION, RESET ALL TIP POSITION ALIGNMENTS AND PERFORMED LUBRICATION. THE ENGINEER RAN MACRO AND PATIENTS WITH NO ERRORS . ON 17 NOVEMBER 2015 THE FSE FOLLOWED-UP WITH THE CUSTOMER. THE CUSTOMER REPORTED THE 2000 ANALYZER RAN ALL NIGHT WITH NO ERRORS AND IS RUNNING SUCESSFULLY.THERE WAS NO FURTHER ACTION REQUIRED BY FIELD SEVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE SORTER THE TIP ALIGNMENTS WERE OFF.

    Description of Event or Problem · 0

    ON (B)(6) 2015 A CUSTOMER REPORTED NO TIP AQUIRED BY SORTER ERRORS WITH THEIR A1A 2000 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 BHCG 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
    222717 AIA-2000 AIA-2000, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-2000LA

    Patients

    Seq Age Sex Outcome Treatment
    1