BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 3000

    MDR report key: 2725019 · Received August 17, 2012

    Report

    Report Number
    2518443-2012-00001
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 5, 2012
    Report Date
    August 15, 2012
    Manufacturer
    CAPINTEC, INC.
    Product Code
    JJJ
    Removal / Correction Number
    5218443-7/18/12/0001-C,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS (CONDUCTED BETWEEN (B)(4) 2012): THE CUSTOMER'S ERROR WAS DUPLICATED USING AN IDENTICAL PRODUCTION UNIT WITH SAME SOFTWARE REVISION. THE ROOT CAUSE WAS IDENTIFIED AS SOFTWARE PROGRAMMING ERRORS WHICH CAUSED THE FOLLOWING PROBLEMS: IF THE USER EITHER EXITS THE THYROID UPTAKE MEASUREMENT MODULE OR PRINTS BEFORE MEASURING RESIDUAL DOSE, THE INTERIM COUNT DATA FOR THE DOSE IS NOT CORRECTLY SAVED TO THE PT'S DATABASE. IF, AFTER EXITING OR PRINTING, THE USER RETURNS TO THE SAME STEP OF THE PROTOCOL WITHOUT TAKING A MEASUREMENT FROM ANOTHER PT, AN ERROR MESSAGE WILL BE DISPLAYED AND THE TEST CANNOT BE COMPLETED. IF THE USER MEASURES A DIFFERENT PT WITH THE CAPTUS 3000 DEVICE BEFORE MEASURING THE RESIDUAL DOSE ON THE FIRST PT, AND THEN RETURNS TO THE "MEASURE LIQUID AND SUBTRACT RESIDUAL" FOR THE FIRST PT, THE MEASURED COUNT DATA FROM THE LAST MEASURED PT WILL BE ERRONEOUSLY STORED IN THE FIRST PT'S FILE. THIS MAY RESULT IN AN ERRONEOUS THYROID UPTAKE VALUE FOR THE FIRST PT. THIS SOFTWARE ERROR IS ISOLATED TO THE "MEASURE LIQUID AND SUBTRACT RESIDUAL" PROTOCOL ONLY, AND OCCURS ONLY IF THE INITIAL DOSE MEASUREMENT SEQUENCE IS INTERRUPTED. THE ERROR DOES NOT OCCUR IN ANY OF THE FOUR OTHER DOSE ADMINISTRATION SELECTION OPTIONS IN THE THYROID UPTAKE PROTOCOL SETUP. CORRECTIVE ACTIONS: CUSTOMER ALERT LETTERS WERE SENT BEGINNING ON (B)(4) 2012 TO ALL (B)(4) AFFECTED CUSTOMERS NOTIFYING THEM OF THE SOFTWARE ERROR AND INSTRUCTING THEM ON USE OF THE SYSTEM PENDING THE DISTRIBUTION OF CORRECTED SOFTWARE, WHICH IS EXPECTED TO BE SENT OUT WITHIN THE NEXT TWO WEEKS. CAPINTEC WILL FOLLOW UP WITH ALL AFFECTED CUSTOMERS TO ASSURE RECEIPT AND INSTALLATION OF CORRECTED SOFTWARE. WE RECEIVED NO REPORTS OF ANY ILLNESS OR INJURY THAT HAS OCCURRED WITH THE USE OF THE DEVICE RELATED TO THIS ERROR.

    Description of Event or Problem · 1

    A NUCLEAR MEDICINE TECHNOLOGIST WAS PERFORMING A THYROID UPTAKE PROCEDURE ON A PT WITH I-123 USING THE CAPINTEC CAPTUS 3000 "MEASURE LIQUID AND SUBTRACT RESIDUAL DOSE" PROTOCOL. THE TECHNOLOGIST ATTEMPTED TO PRINT THE PT DATA BEFORE COMPLETING THE DOSE MEASUREMENT SEQUENCE AND GOT A RUN TIME ERROR 13 MESSAGE, WHICH CAUSED THE SOFTWARE TO EXIT THE CAPTUS 3000 PROGRAM. AFTER LOGGING BACK ON TO THE CAPTUS 3000 PROGRAM, THE PREVIOUSLY MEASURED DOSE DATA WERE MISSING. THE PT DEMOGRAPHICS DATA WERE NOT AFFECTED AND PRINTED CORRECTLY. TECHNOLOGIST CONFIRMED THAT SHE DID INITIALLY PERFORM DOSE MEASUREMENTS. WITH ASSISTANCE FROM CAPINTEC CUSTOMER SUPPORT, THE TECHNOLOGIST WAS ABLE TO COMPLETE THE TEST MANUALLY USING THE MULTI CHANNEL ANALYZER (MCA) PROGRAM AVAILABLE ON THE CAPTUS 3000 USING PREVIOUSLY MEASURED COUNT DATA FROM AN EQUIVALENT LIQUID I-123 DOSE. THE PT DID NOT REQUIRE REPEAT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTUS 3000 THYROID UPTAKE AND WELL COUNTER SYSTEM JJJ CAPINTEC, INC. CAPTUS 3000

    Patients

    Seq Age Sex Outcome Treatment
    1