ENS Event | |
|---|---|
04:00 Apr 1, 2026 | |
| Title | Potential Medical Event |
| Event Description | The following information was provided by the licensee via phone:
On April 1, 2026, the radiation safety officer (RSO) at BAMF Health Clinic received notification from their clinical trial sponsor, Heart Bio, that they identified unexpected trace amounts of thorium-228 in their ARTISAN AB001-101 trial medication that is currently being tested and administered via intravenous injection. The sponsor's preliminary dose analysis estimated that four different organs and tissues will receive over 50 rem to each organ from the thorium contaminate. The RSO is assisting Heart Bio in their investigation to identify the full scope of patients affected by the medication. The treating physician and the Food and Drug Administration (FDA) has been notified. The sponsor and an independent institutional review board are working with the RSO to notify the research patients. 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.
The following information was provided by the licensee via phone: Following consultation with Region III, it was determined that this event does not meet the medical event reporting criteria under 10 CFR 35.3045. The condition resulted from impurities introduced during the manufacturing process rather than from a misadministration of radioactive material, and therefore is not reportable under this provision. Notified R3DO (Ruiz), NMSS (DiMarco), and NMSS Events Notification (email). |
| Where | |
|---|---|
| Bamf Health Management, Llc Grand Rapids, Michigan (NRC Region 3) | |
| License number: | 21-35632-03MD |
| Organization: | Bamf Health Management, Llc |
| Reporting | |
| 10 CFR 35.3045(a)(1)(ii) | |
| Time - Person (Reporting Time:+38.73 h1.614 days <br />0.231 weeks <br />0.0531 months <br />) | |
| Opened: | Colten Conrad 18:44 Apr 2, 2026 |
| NRC Officer: | Ian Howard |
| Last Updated: | Apr 16, 2026 |
| 58230 - NRC Website | |
Bamf Health Management, Llc with 10 CFR 35.3045(a)(1)(ii) | |
WEEKMONTHYEARENS 582302026-04-01T04:00:0001 April 2026 04:00:00
[Table view]10 CFR 35.3045(a)(1)(ii) Potential Medical Event 2026-04-01T04:00:00 | |