PNO-IV-97-028, on 970403,female Patient Administered 10 Mci of Sodium Iodide I-131 for Treatment of Graves Disease in Accordance W/Written Directive Prepared by Authorized User. Lab Tests Revealed Patient Was Pregnant
| ML20141C706 | |
| Person / Time | |
|---|---|
| Site: | 03029534 |
| Issue date: | 05/16/1997 |
| From: | Mark Shaffer, Spitzberg D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| References | |
| PNO-IV-97-028, PNO-IV-97-28, NUDOCS 9705190162 | |
| Download: ML20141C706 (2) | |
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- May 16,1997 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-IV-97-028 i
This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by Region IV staff in Arlington, Texas on this date.
Facility Licensee Emeraency Classification Department Of The Army Notification of Unusual Event Evans Army Community Hospital Alert Buillding 7500 Site Area Emergency Fort Carson, Colorado 80913 5101 General Emergency Dockets: 03029534 License No: 05-26854-01 X Not Applicable
Subject:
MEDICAL EVENT INVOLVING DOSE TO EMBRYO / FETUS On May 16,1997, Region-IV received telephonic notification frc,m the licensee of a medical event that occurred on April 3,1997, at the licensee's facility in Fort Carson, Colorado. The j
licensee reported that on April 3,1997, a fernale patient was administered 10 millicuries of sodium iodide iodine-131 for the treatment of Graves disease in accordance with the written directive 'vepared by an authorized user. In accordance with the licensee's written quality management program, a pregnancy test was performed in the hospital's clinicallaboratory for the patient prior to administration of the dose. Following completion of the tests, the laboratory results were forwarded to the authorized user. Upon review of the test results, the authorized user incorrectly interpreted the results to be negative, indicating that the patient was not pregnant. The licensee then proceeded with the nuclear medicine procedure and administered the iodine-131 to the patient.
On May 8,1997, the patient contacted her primary care physician to report that she was feeling nauseous. The physician examined the patient and ordered laboratory tests to be performed, including a pregnancy test. Laboratory tests revealed that the patient was pregnant. Based the calculated date of conception, the licensee estimates that the patient was in the seventh day of her prenanc:y on April 3rd when the radiopharmaceutical was administered.
4 Following notification that the patient was pregnant, the licensee contacted the Radiation Internal Dose information' Center (RIDIC) in Oak Ridge, Tennessee, for assistance in calculating the dose to the embryo / fetus. Using information provided by the licensee, RIDIC calculated a dose of 1.3 rems to the patient's uterus. Based on data contained in NCRP Report No. 9, j
the licensee does not expect any adverse health effects to the embryo / fetus, j
The licensee has notified the patient of the medical event, and has provided her with j
information from the NCRP report which indicates a probability of less than 1 percent that i
stocastic effects would result from a dose of less than 5 rems to the embryo / fetus.
9705190162 970516 I
PDR I&E 4q PNO-IV-97-028 PDR JMOM g
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-2 The state of Colorado will be informed.
Region IV received notification of this occurre'nce by telephone from one of the licensee's authorized users at 11:15 am (CDT) on May 16,1997. Region IV has informed NMSS.
Region-IV intends to dispatch an inspector to review this event during the week of May 19, 1997. The region also intends to request the assistance of a medical physician consultant to I
review this event.
This information has been discussed with the licensee and is current as of 1:30 p.m. (CDT) on May 16,1997.
Contact:
Mark R. Shaffer D. Blair Spitzberg (817)860-8287 (817)860-8191 3
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