FDA Adverse Event Other Summary report: N

MULTISITE 3 BRACANALYSIS

MDR report key: 1556580 · Received December 4, 2009

Report

Report Number
MW5013859
Event Type
Other
Date Received
December 4, 2009
Date of Event
February 5, 2007
Report Date
December 4, 2009
Manufacturer
MYRIAD GENETIC LABORATORIES
Product Code
OQS
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

DURING A ROUTINE VISIT WITH HER GYNECOLOGIST, THIS PT MENTIONED THAT HER SISTER WAS DIAGNOSED WITH BREAST CANCER. THE GYNECOLOGIST OFFERED THE PT A BLOOD TEST TO BETTER ASSESS HER OWN RISK FOR DEVELOPING BREAST CANCER. A FEW WEEKS LATER, THE PT RECEIVED A CALL AT WORK FROM AN ASSISTANT AT HER GYNECOLOGIST'S OFFICE. THE PT IS AN ELEMENTARY SCHOOL TEACHER AND WAS IN THE MIDDLE OF HER CLASSROOM AT THE TIME OF THIS CALL. THE ASSISTANT INDICATED THAT HER TEST RESULTS WERE AVAILABLE AND THAT SHE NEEDED TO MEET WITH THE GYNECOLOGIST AS SOON AS POSSIBLE. THE PT WAS FRIGHTENED AND ASKED ABOUT HER RESULTS. THE OFFICE ASSISTANT REVEALED THAT THE PT WAS FOUND TO CARRY A BRCA2 MUTATION. WHEN SHE ASKED TO SPEAK WITH HER GYNECOLOGIST IMMEDIATELY, SHE WAS TOLD THAT NO ONE AT HER PHYSICIAN'S OFFICE WAS AVAILABLE TO SPEAK WITH HER UNTIL THE FOLLOWING WEEK. SHE DESCRIBED HERSELF AS 'DISTRAUGHT'. WHEN SHE FINALLY DID GET TO MEET WITH HER GYNECOLOGIST, SHE WAS TOLD THAT SHE NEEDED A TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL MASTECTOMIES. NO OTHER OPTIONS WERE PRESENTED. SHE WAS SHOCKED AND OVERWHELMED, ESPECIALLY SINCE SHE HAD NOT BEEN TOLD THAT THE TEST WOULD DETERMINE HER RISKS FOR OVARIAN CANCER. SHE WAS THEN REFERRED TO A CERTIFIED GENETIC COUNSELOR WHERE SHE LEARNED FOR THE FIRST TIME THE RISKS TO HER CHILDREN AND HER OPTIONS FOR CANCER SURVEILLANCE AND RISK REDUCTION. SHE REMARKED THAT SHE WISHED SHE HAD RECEIVED THIS INFO BEFORE SHE HAD TESTING. SHE INDICATED THAT SHE MIGHT NOT HAVE HAD THE TEST IF SHE HAD KNOWN ALL OF THE INFO AND IMPLICATIONS OF THE TEST RESULTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MULTISITE 3 BRACANALYSIS COMMON JEWISH BRCA MUTATIONS OQS MYRIAD GENETIC LABORATORIES

Patients

Seq Age Sex Outcome Treatment
1