ENS 43443
ENS Event | |
|---|---|
04:00 Jun 19, 2007 | |
| Title | Agreement State Report Involving Higher than Prescribed Dose Delivered |
| Event Description | The following notification was received from the State of NY Bureau of Environmental Radiation Protection via fax:
AS Agency -New York State Department of Health Event Report - ID # NYS DOH 07-002 Licensee Name and License Number - Withheld as per NYS Law Event Date - June 19, 2007 Event Type - Medical Event Event Description: A medical event involving yttriurn-90 Zevalin (Ibritumomab Tiuxetan) for treatment of non-Hodgkin's lymphoma was reported to NYS DOH by telephone on June 22, 2007. The authorized physician user (AU) approved a dosage of 29 mCi for treatment on June 19, 2007, however a dose of 36.7 mCi was administered. This Zevalin patient (A) was scheduled to receive treatment at the hospital on June 19, 2007. The radiopharmacy prepared the dose but observed that the assay from the supplier was approximately 10 mCi higher than their assay. They reviewed their data including their most recent calibration of the dose calibrator with a NIST traceable syringe standard. They decided to use their NIST traceable calibration factor and associated assay. The dose was dispensed and the patient was treated. Another Zevalin patient (B) was scheduled for treatment on June 20, 2007. In preparing patient B's dose the radiopharmacy observed the same condition as with patient A's assay. At this point they realized they had a problem and patient B's dose was not dispensed. An investigation began. The radiopharmacy identified the error. They used an AEA Technology QSA Inc. model SIM.SY2 (Sealed Source Registry No. MA-1059-S-360-S) to calibrate their Capintec CRC-15R dose calibrator as well as the hospital's dose calibrator. This source is specifically designed to calibrate Capintec CRC-15R units for yttrium 90 assays. The calibration source label has an assay of 20mCi (740 MBq) of strontium 90/ytrrium 90 and a calibration date of Nov. 14, 2004. However, the source certificate lists the yttrium 90 'Equivalent Activity' as 30.68 mCi (1135 MBq), which is the value that should have been used for the calibration. Apparently the certificate was not available (misplaced?) on June 8 &10 for the calibration. The radiopharmacy used the decay-corrected value from the label rather than a decay-corrected value of the certificate's 'Equivalent Activity'. Since the same calibration error was performed on the hospital's dose calibrator, the hospital's assay matched up with that of the radiopharmacy and with the intended dosage. The patient's daughter and the referring physician were notified on the day after discovery. The treating physician is assessing situation and the possible effects to the patient. Intended dose - 29 mCi Delivered dose - 37.6 mCi Date of treatment - 6/20/07 Date of error discovered - 6/20/07 Isotope/drug - yttrium-90/Zevalin Reported/notification dates: "Patient/patient rep. - 6/20/07 "Referring MD - 6/20/07 "NYS DOH - 6/22/07 Cause: Dose calibrator calibration error Effect - patient's condition and effects are being assessed Investigation - RCA required Initial Written report due 6/29/07
This event (EN43443) has been reviewed and determined to be a reportable medical event. A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |
| Where | |
|---|---|
| Unknown Troy, New York (NRC Region 1) | |
| Organization: | New York State Dept. Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+156.75 h6.531 days <br />0.933 weeks <br />0.215 months <br />) | |
| Opened: | Robert Dansereau 16:45 Jun 25, 2007 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Jun 26, 2007 |
| 43443 - NRC Website | |
Unknown with Agreement State | |
WEEKMONTHYEARENS 572262024-07-15T12:59:00015 July 2024 12:59:00
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Orphaned Source Discovered / Possible Overexposure Involved ENS 513152015-07-13T13:45:00013 July 2015 13:45:00 Agreement State Agreement State Report - Ndc Gauge Recovered from Landfill ENS 511962015-06-01T06:00:0001 June 2015 06:00:00 Agreement State Colorado Agreement State Report - Radium-226 Discovered at Scrap Yard ENS 509862015-04-15T19:15:00015 April 2015 19:15:00 Agreement State Agreement State Report - Source Discovered at a Transfer Station ENS 511012015-04-14T05:00:00014 April 2015 05:00:00 Agreement State Agreement State Report - Cs-137 Found in Waste Entering a Landfill ENS 509722015-04-10T04:00:00010 April 2015 04:00:00 Agreement State Agreement State Report - Radium-226 Source Found in Load of Scrap Metal ENS 502282014-06-23T07:00:00023 June 2014 07:00:00 Agreement State Agreement State Report - Damaged Fixed Gauge Found in Scrap Metal Shipment ENS 499642014-03-26T04:00:00026 March 2014 04:00:00 Agreement State Agreement State Report - Y-90 Sir-Spheres Treatment Dose Less than Prescribed ENS 498432014-02-07T06:00:0007 February 2014 06:00:00 Agreement State Agreement State Report - Unknown Radioactive Material Discovered in Garbage Truck at Landfill ENS 495132013-10-31T05:00:00031 October 2013 05:00:00 Agreement State Orphan Sealed Source Recovered at a Scrap Yard ENS 491462013-06-24T18:30:00024 June 2013 18:30:00 Agreement State Agreement State Report - Scrap Metal Shipment Found to Contain Unidentified Radioactive Material ENS 490352013-04-24T06:00:00024 April 2013 06:00:00 Agreement State Agreement State Report - Found Radium 226 Source ENS 487992013-03-01T05:00:0001 March 2013 05:00:00 Agreement State Agreement State Report - Shipment Containing Cesium-137 Found ENS 487532013-02-14T08:00:00014 February 2013 08:00:00 Agreement State Agreement State Report - Discovery of Gas Chromatograph in Building Attic ENS 488152013-02-14T04:00:00014 February 2013 04:00:00 Agreement State Blackout Button Found in Load of Scrap Metal ENS 487282013-01-28T05:00:00028 January 2013 05:00:00 Agreement State Agreement State Report - Smoke Detectors Found at Scrap Metal Recycling Facility ENS 491182012-11-19T07:00:00019 November 2012 07:00:00 Agreement State Agreement State Report - Illegal Transfer of a Device Containing Americium-241 ENS 479632012-05-25T05:00:00025 May 2012 05:00:00 Agreement State Agreement State Report - Uranium Source Found at Metal Check Recycling Facility ENS 477922012-03-28T20:35:00028 March 2012 20:35:00 Agreement State Agreement State Report - a Moisture Density Gauge Was Found in Building ENS 476132012-01-19T05:00:00019 January 2012 05:00:00 Agreement State Agreement State Report - Radium-226 Sources Discovered at Waste Transfer Station ENS 475592011-12-28T07:00:00028 December 2011 07:00:00 Agreement State Agreement State Report - Two Nuclear Gauges Found at Metal Recycling Facility ENS 473972011-10-28T17:00:00028 October 2011 17:00:00 Agreement State Agreement State Report - Orphaned Source Discovered at a Scrap Metal Facility ENS 473962011-10-13T16:00:00013 October 2011 16:00:00 Agreement State Agreement State Report - Dose Misadministration ENS 462132010-08-03T06:00:0003 August 2010 06:00:00 Agreement State Agreement State Report - Radioactive Material Found in Scrap Shipment ENS 461472010-08-02T05:00:0002 August 2010 05:00:00 Agreement State Agreement State Report Involving a Source Found in a Load of Scrap ENS 460612010-06-24T16:00:00024 June 2010 16:00:00 Agreement State Agreement State Report Involving a Found Ra-226 Source ENS 459542010-05-21T04:00:00021 May 2010 04:00:00 Agreement State Agreement State Report - Lost Source Found in Scrap Metal ENS 458192010-04-07T05:00:0007 April 2010 05:00:00 Agreement State Agreement State - Depleted Uranium Found in Scrap Metal ENS 458022010-03-29T06:00:00029 March 2010 06:00:00 Agreement State Agreement State Report - Found Portable Density Gauge ENS 456102010-01-04T06:00:0004 January 2010 06:00:00 Agreement State Agreement State - Moisture Density Gauge Found in Scrap Metal ENS 446902008-11-22T19:00:00022 November 2008 19:00:00 Agreement State Agreement State Report - Radium Vials Discovered in Home ENS 444642008-08-08T07:00:0008 August 2008 07:00:00 Agreement State Agreement State Report Involving a Lost or Stolen Tritium Exit Sign ENS 440582008-03-12T18:30:00012 March 2008 18:30:00 Agreement State Agreement State - Unidentified Radioactive Material Received at Metal Recycling Facility ENS 438112007-11-28T01:11:00028 November 2007 01:11:00 Agreement State Agreement State Report - Naturally Occurring Radioactive Material Found at a School ENS 436812007-09-28T17:00:00028 September 2007 17:00:00 Agreement State Wisconsin Agreement State Report - 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Radioactive Material Identified in Arc Furnace Ash ENS 427092006-07-15T05:00:00015 July 2006 05:00:00 Agreement State Louisiana Agreement State Report of Radioactive Source Found at Old Texaco Site ENS 419492005-08-26T05:00:00026 August 2005 05:00:00 Agreement State Agreement State - Tritium Exit Signs Found in Recyclables ENS 419302005-08-15T04:00:00015 August 2005 04:00:00 Agreement State Agreement State Report - Source of Unknown Origin Found in Railcar ENS 409302004-08-05T05:00:0005 August 2004 05:00:00 Agreement State Agreement State - Recovered Device Containing Radioactive Material ENS 408512004-06-30T22:30:00030 June 2004 22:30:00 Agreement State Agreement State Report from the New York City Bureau of Rad Health ENS 402392003-10-10T04:00:00010 October 2003 04:00:00 Agreement State Agreement State Report Involving Discovery of Nuclear Gauge in Scrapyard ENS 401542003-09-09T07:00:0009 September 2003 07:00:00 Agreement State Agreement State Report Involving a Recovered Source 2024-07-15T12:59:00 | |