FDA Adverse Event Other Summary report: N

BRCANALYSIS

MDR report key: 1556579 · Received December 4, 2009

Report

Report Number
MW5013858
Event Type
Other
Date Received
December 4, 2009
Date of Event
June 30, 2007
Report Date
December 4, 2009
Manufacturer
MYRIAD GENETIC LABORATORIES, INC.
Product Code
OQS
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

THIS PT IS A FEMALE WHO WAS DIAGNOSED WITH A CLEAR CELL CARCINOMA OF THE OVARY. SHE HAS A FAMILY HISTORY OF WHICH INCLUDES ONE CASE OF ENDOMETRIAL CANCER, ONE CASE OF BREAST CANCER, AND SEVERAL CASES OF COLORECTAL CANCER INCLUDING ONE CASE OF EARLY-ONSET RECTAL CANCER IN A MATERNAL AUNT DIAGNOSED. THIS PT WAS TESTED BY HER ONCOLOGIST IN 2007 FOR MUTATIONS IN THE BRCA1/2 GENES -ASSOCIATED WITH HEREDITARY BREAST AND OVARIAN CANCER- AND TESTED NEGATIVE. SHE WAS TOLD THAT HER CANCER WAS NOT DUE TO A HEREDITARY CAUSE AND WAS NOT OFFERED ANY FURTHER GENETIC TESTING. HER MOTHER THEN PURSUED GENETIC TESTING IN 2008 AND LEARNED THAT SHE CARRIES A MUTATION IN THE MSH2 GENE ASSOCIATED WITH HEREDITARY NONPOLYPOSIS COLORECTAL CANCER -HNPCC OR LYNCH SYNDROME- ASSOCIATED WITH COLORECTAL, ENDOMETRIAL, AND OVARIAN CANCERS. THIS PT WAS THEN REFERRED FOR GENETIC COUNSELING AND TESTING, AND LEARNED THAT SHE CARRIES THE MSH2 MUTATION FOUND IN HER FAMILY. THIS PT WAS VERY ANGRY AND UPSET THAT HER TEST RESULTS WERE MISINTERPRETED IN 2007, AND AS A RESULT, SHE HAD BEN TOLD THAT HER CANCER WAS NOT DUE TO A HEREDITARY CAUSE. SHE WAS ANGRY THAT SHE HAD NOT BEEN OFFERED TESTING FOR HNPCC IN 2007 AND WAS NOW LEARNING 2 YEARS LATER THAT SHE CARRIES A MSH2 MUTATION AND HER CANCER WAS IN FACT DUE TO A HEREDITARY CAUSE. SHE ALSO HAD NOT BEEN HAVING THE SCREENING -INCLUDING YEARLY COLONOSCOPY AND ENDOSCOPY- THAT WOULD HAVE BEEN RECOMMENDED HAD HER MUTATION STATUS BEEN IDENTIFIED AT THAT TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BRCANALYSIS BRCA1 GENE TESTING OQS MYRIAD GENETIC LABORATORIES, INC.
2 BRCANALYSIS BRCA2 GENE TESTING ODJ MYRIAD GENETIC LABORATORIES, INC.

Patients

Seq Age Sex Outcome Treatment
1 37 YR