ENS 45910
ENS Event | |
|---|---|
18:45 Apr 23, 2010 | |
| Title | Agreement State Report - External Radiation Levels Exceed Limits |
| Event Description | The following was received via email from the Commonwealth of Massachusetts:
Lantheus Medical Imaging (LMI) received a customer complaint on 4/23/10 from a customer (GE Healthcare in Tampa, FL) reporting a reading of 310 mR/hr on a Tc-99m generator that was manufactured on 4/22/10 at the facility in Billerica, MA. On 4/27/10, LMI was able to clarify that the reading was on the package surface rather than on the generator itself. The customer reported the situation to the Florida Bureau of Radiation Control on 4/28/10. LMI has been investigating and have not yet found any evidence of a problem with this generator in their manufacturing records. LMI will continue to investigate and will be receiving the generator back from the customer in the next week or so. They will then examine it directly. The R1DO (Cook) and FSME (Suber) have been notified.
The Commonwealth clarified their report that the TC-99m generator is actually a Mo-99 generator. Notified R1DO (Gray) and FSME (McIntosh).
The following was received via fax from the Commonwealth of Massachusetts: This updated information is taken from Lantheus Medical Imaging letter dated June 11, 2010. Lantheus Medical Imaging received the generator back from the customer on 5/10/10 and performed tests and inspections on the unit. LMI found no evidence of any defect or condition that could have caused the high reading. Their radiation levels measured on 5/10/10 and back decayed for this generator on the day of manufacture was reported as 140 mR/hr. LMI reports there are only two scenarios to explain the high readings: 1, Migration of Tc-99m activity out to an unshielded section of the fluid path while the generator was in transit. LMI reports that this would involve an as yet unknown failure mode since all required fittings and plugs were in place at time of inspection of the returned generator. 2. The 310 mR/hr reading is in error, given that the customer reported a normal TI value, (i.e., 4.6 mR/hr measured vs. 5.2 mR/hr label value), a high reading Is difficult to explain, and the customer could shed no light on this apparent discrepancy. Based on the reported measurements of the returned generator which were back decay calculated to 140 mR/hr, it appears that the labeled TI value was correct. The customer's TI measurements agreed with the labeled TI value. The Agency [Commonwealth] considers this event to be closed. Notified R1DO (Joustra) and FSME (Villamar) |
| Where | |
|---|---|
| Lantheus Medical Imaging North Billerica, Massachusetts (NRC Region 1) | |
| License number: | 60-0088 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+331.83 h13.826 days <br />1.975 weeks <br />0.455 months <br />) | |
| Opened: | John Sumares 14:35 May 7, 2010 |
| NRC Officer: | Eric Simpson |
| Last Updated: | Jul 16, 2010 |
| 45910 - NRC Website | |
Lantheus Medical Imaging with Agreement State | |
WEEKMONTHYEARENS 556442021-12-13T05:00:00013 December 2021 05:00:00
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