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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 54143 | 1 July 2019 04:00:00 | Agreement State | Agreement State Report - Patient Underdose | The following was received via email: On 7/2/2019, the Ohio Department of Health received a phone call from Nationwide Children's Hospital reporting a medical event. The licensee was treating acute myeloid leukemia (AML) with I-131 Iomab using a delivery system that is currently under research and development. The licensee stated the delivery system does not allow the dose vial to be seen and requires the manufacturer to set the infusion time. After the infusion, the technicians discovered the delivery system did not deliver the entire dose to the patient, resulting in an underdose of 42 percent. The patient and referring physician have been notified. An investigation of the event is pending. Ohio Item Number: OH190010 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. |