ENS 55537

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v t e ENS Event
19:20 Oct 20, 2021
Title	Underdose
Event Description	The following report was received from the Illinois Emergency Management Agency [the Agency] via email: The Agency was contacted on the afternoon of 10/21/21 by the University of Chicago to advise of a reportable medical event that occurred the day before. A human research subject was reportedly administered 79.8 mCi of a prescribed 100 mCi dose of I-131 under the therapeutic portion of a study protocol. There is no root cause available at this time, although the licensee suspects an inadequate volume of saline flush. Inspectors will evaluate any other contributing factors including equipment, personnel involved and unique procedures for this study protocol. At this time, the licensee is not expecting any adverse impact to the patient and they are following up with the study sponsor to determine if additional treatment is required. The referring physician has been notified and the licensee is aware of the requirement to notify the patient. This matter is reportable under 32 Ill. Adm. Code 335.1080(a) for a dose differing from the prescribed dose by 20 percent or more. The administration was started at 1420 CDT on 10/20/21 and the matter reported to the Agency at 1219 CDT on 10/21/21. The reporting criteria has been met. In accordance with Agency policy, inspectors will perform a reactionary inspection within 10 days of the incident. Illinois Report Number: IL210032 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.

ENS 55537 +/-
Where
University Of Chicago Medical Center Chicago, Illinois (NRC Region 3)
License number:	Il-01678-02
Organization:	Illinois Emergency Mgmt. Agency
Reporting

Agreement State
Time - Person (Reporting Time:+21.7 h0.904 days <br />0.129 weeks <br />0.0297 months <br />)
Opened:	Gary Forsee 17:02 Oct 21, 2021
NRC Officer:	Brian P. Smith
Last Updated:	Oct 21, 2021
55537 - NRC Website
v • d • e

v t e Emergency Notification System
University Of Chicago Medical Center with Agreement State
WEEKMONTHYEAR2021-10-20T19:20:00 [Table view]
[ENS list for University Of Chicago Medical Center]

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