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The following notification was received fr … The following notification was received from the State of NY Bureau of Environmental Radiation Protection via fax:</br>AS Agency -New York State Department of Health</br>Event Report - ID # NYS DOH 07-002</br>Licensee Name and License Number - Withheld as per NYS Law</br>Event Date - June 19, 2007</br>Event Type - Medical Event</br>Event Description:</br>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.</br>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.</br>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.</br>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.</br>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.</br>Intended dose - 29 mCi</br>Delivered dose - 37.6 mCi</br>Date of treatment - 6/20/07</br>Date of error discovered - 6/20/07</br>Isotope/drug - yttrium-90/Zevalin</br>Reported/notification dates:</br> "Patient/patient rep. - 6/20/07</br> "Referring MD - 6/20/07</br> "NYS DOH - 6/22/07</br>Cause: Dose calibrator calibration error</br>Effect - patient's condition and effects are being assessed</br>Investigation - RCA required</br>Initial Written report due 6/29/07</br>* * * UPDATE AT 1107 EDT ON 6/26/07 FROM FSME (FLANNERY) TO JASON KOZAL VIA EMAIL * * *</br>This event (EN43443) has been reviewed and determined to be a reportable medical event.</br>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.not necessarily result in harm to the patient.
04:00:00, 19 June 2007 +
16:45:00, 25 June 2007 +
04:00:00, 19 June 2007 +
The following notification was received fr … The following notification was received from the State of NY Bureau of Environmental Radiation Protection via fax:</br>AS Agency -New York State Department of Health</br>Event Report - ID # NYS DOH 07-002</br>Licensee Name and License Number - Withheld as per NYS Law</br>Event Date - June 19, 2007</br>Event Type - Medical Event</br>Event Description:</br>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.</br>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.</br>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.</br>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.</br>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.</br>Intended dose - 29 mCi</br>Delivered dose - 37.6 mCi</br>Date of treatment - 6/20/07</br>Date of error discovered - 6/20/07</br>Isotope/drug - yttrium-90/Zevalin</br>Reported/notification dates:</br> "Patient/patient rep. - 6/20/07</br> "Referring MD - 6/20/07</br> "NYS DOH - 6/22/07</br>Cause: Dose calibrator calibration error</br>Effect - patient's condition and effects are being assessed</br>Investigation - RCA required</br>Initial Written report due 6/29/07</br>* * * UPDATE AT 1107 EDT ON 6/26/07 FROM FSME (FLANNERY) TO JASON KOZAL VIA EMAIL * * *</br>This event (EN43443) has been reviewed and determined to be a reportable medical event.</br>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.not necessarily result in harm to the patient.
Has query"Has query" is a predefined property that represents meta information (in form of a <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Subobject">subobject</a>) about individual queries and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
Yttriurn-90 + and Yttrium 90 +
00:00:00, 26 June 2007 +
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02:16:27, 2 March 2018 +
16:45:00, 25 June 2007 +
6.531 d (156.75 hours, 0.933 weeks, 0.215 months) +
04:00:00, 19 June 2007 +
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