BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 2000

    MDR report key: 301114 · Received October 17, 2000

    Report

    Report Number
    MW1020203
    Event Type
    Malfunction
    Date Received
    October 17, 2000
    Date of Event
    August 30, 2000
    Report Date
    October 17, 2000
    Manufacturer
    CAPINTEC INC, SERVICE AND CUSTOMER SUPPORT
    Product Code
    JZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN PERFORMED A BIOASSAY FOLLOWING THE ADMINISTRATION OF IODINE 131 THE DAY BEFORE. AFTER ENTERING THE BIOASSAY MENU AND ACCESSING NAME, GOT AN "ILLEGAL FUNCTION CALL" ERROR WHICH WOULD NOT ALLOW ACCESS TO PERFORM BIOASSAY, AND WOULD ALSO NOT ALLOW ACCESS TO PREVIOUS DIRECTORY OF BIOASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTUS 2000 THYROID UPTAKE SYSTEM JZO CAPINTEC INC, SERVICE AND CUSTOMER SUPPORT 2311 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other