BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 2575177 · Received September 9, 2011

    Report

    Report Number
    2915056-2011-00007
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    January 27, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF GE HEALTHCARE SALES ORDER (B)(4) DETERMINED THAT THE CAUSE SEEDS OF THE INCORRECT ACTIVITY BEING SUPPLIED WAS A DATA-ENTRY ERROR IN THE CUSTOMER SERVICE DEPARTMENT WHEN THE RADIOPHARMACY'S ORDER WAS KEYED INTO THE INTERNAL COMPUTERIZED INVENTORY SYSTEM (SAP): ACTIVITY WAS ENTERED AS 0.254 MCI INSTEAD OF 0.234 MCI. THIS CAUSED THE ORDER TO BE FILLED WITH SEEDS OF THE INCORRECT ACTIVITY. REVIEW OF THE BATCH RECORD FOR 090801 SHOWED NO RELEVANT DEVIATIONS OR INVESTIGATIONS, ALL RELEASE SPECIFICATIONS WERE MET. THE SEEDS WERE DISPATCHED TO TRIAD ISOTOPES FOR ONWARD TRANSMISSION TO THE USER FACILITY. THE LABELED ACTIVITY REFLECTED THAT IN SAP, I.E., 0.254 MCI; HOWEVER, THE DISCREPANCY WITH THE RADIOPHARMACY'S ORDER WAS NOT NOTED BEFORE THE SEEDS WERE SENT TO THE USER FACILITY. REVIEW OF PRODUCT COMPLAINT RECORDS SHOWED NO SIMILAR INCIDENTS INDICATING THAT THERE WAS NO TREND OF INCORRECT DATA ENTRY OF ORDERS AT THE CUSTOMER SERVICE DEPARTMENT AND THE INVESTIGATION WAS CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A MALE PT WAS SCHEDULED FOR IMPLANTATION OF 80 IODINE (I-125) BRACHYTHERAPY SEEDS OF MEDIAN ACTIVITY 0.234MCI AT THE REFERENCE DATE ((B)(6) 2010). BEFORE IMPLANTATION, THE FACILITY DETERMINED THAT THE MEDIAN ACTIVITY OF THE SEEDS WAS 0.254MCI AT THE REFERENCE DATE. THE PT TREATMENT PLAN WAS ADJUSTED AND THE IMPLANTATION PERFORMED ON (B)(6) 2010 USING THE SUPPLIED SEEDS; NO ADVERSE EXPERIENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IODINE (I-125) SEEDS BRACHYTHERAPY IMPLANT KXK GE HEALTHCARE 6711 090841

    Patients

    Seq Age Sex Outcome Treatment
    1