FDA Adverse Event Other Summary report: N

COMPREHENSIVE BRACANALYSIS

MDR report key: 1556575 · Received December 7, 2009

Report

Report Number
MW5013854
Event Type
Other
Date Received
December 7, 2009
Date of Event
September 15, 2008
Report Date
December 7, 2009
Manufacturer
MYRIAD GENETIC LABORATORIES
Product Code
OQS
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PT WAS SEEN BY ME, A GENETIC COUNSELOR, FOR EDUCATION AND SUPPORTIVE COUNSELING AFTER HAVING BEEN TESTED BY HER GYNECOLOGIST AND TOLD THAT SHE HAS A BRCA2 GENE MUTATION. SHE SAID THAT HER MOTHER HAD BEEN DIAGNOSED WITH BREAST CANCER AND THAT HER GYNECOLOGIST RECOMMENDED BRCA TESTING, NOT TO HER MOTHER BUT TO HER, WHICH IS NOT THE MOST INFORMATIVE WAY OF TESTING FROM A GENETICS STANDPOINT. THE PT EXPLAINED THAT SHE WAS NOT TOLD WHAT INFO THIS TEST WOULD PROVIDE HER, NOR WAS SHE TOLD WHAT RISKS SHE WOULD FACE IF SHE TESTED POSITIVE. ALTHOUGH CLEARLY I ONLY HEARD HER SIDE OF THE STORY, IT SOUNDS LIKE THIS WAS NOT TRULY INFORMED CONSENT. WHEN SHE CAME TO ME, SHE SAID, SHE FOUND ME VIA THE INTERNET AND WAS NOT GIVEN A REFERRAL TO ME FROM HER DOCTOR. SHE WAS VERY ANGRY THAT SHE HAS HAD THIS TESTING DONE. SHE SAID THAT HAD SHE KNOWN WHAT INFO SHE WOULD LEARN WITH THIS TESTING, THAT SHE WOULD NEVER HAVE HAD IT DONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COMPREHENSIVE BRACANALYSIS BRCA TESTING OQS MYRIAD GENETIC LABORATORIES

Patients

Seq Age Sex Outcome Treatment
1 24 YR