FDA Adverse Event Other Summary report: N

BRCANALYSIS

MDR report key: 1556574 · Received December 4, 2009

Report

Report Number
MW5013853
Event Type
Other
Date Received
December 4, 2009
Date of Event
February 20, 2008
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 IS A WOMAN WITH A MINIMAL MATERNAL FAMILY HISTORY OF BREAST CANCER. SHE WAS EVALUATED BY HER MOTHER'S BREAST SURGEON BASED ON HER CONCERNS ABOUT HER BREAST CANCER RISK DUE TO HER FAMILY HISTORY AND A QUESTIONABLE MAMMOGRAM FINDING AND THE SURGEON ORDERED GENETIC TESTING. THE PT WAS NOTIFIED VIA TELEPHONE BY THE SURGEON'S SECRETARY THAT HER RESULTS WERE, NORMAL AND SHE WAS 'FINE'. SHE REQUESTED A HARD COPY OF THE RESULTS. UPON READING THE HARD COPY OF HER TEST RESULTS WHICH SHE RECEIVED IN THE MAIL, SHE THOUGHT THAT THE CANCER RISKS QUOTED IN THE LABORATORY REPORT DID NOT SEEM "NORMAL" OR "FINE". SHE REALIZED THAT THE RESULTS WERE NOT NORMAL AND IN FACT HER REPORT CLEARLY INDICATED THAT SHE HAD TESTED "POSITIVE FOR A DELETERIOUS MUTATION" IN THE BRCA1 GENE. SHE CALLED THE SURGEON'S SECRETARY AND EXPLAINED WHAT SHE HAD READ. SHE ALSO MET WITH A GENETIC COUNSELOR WHO CONFIRMED HER RESULTS AND DISCUSSED THE IMPLICATIONS AND APPROPRIATE MEDICAL MANAGEMENT OPTIONS FOR HER AND HER FAMILY. IF SHE HAD NOT RECEIVED THE HARD COPY OF HER TEST RESULTS, READ THROUGH THEM CAREFULLY, AND REALIZED THAT THE INFO IN THE REPORT DID NOT SEEM CONSISTENT WITH WHAT SHE WAS TOLD, THIS PT WOULD HAVE MISTAKENLY THOUGHT THAT SHE WAS NOT AT INCREASED RISK FOR BREAST AND OVARIAN CANCER. IN ADDITION, SINCE HER FAMILY HISTORY IS NOT STRIKING, SHE AND HER OTHER PHYSICIANS WOULD LIKELY NOT HAVE THOUGHT SHE WAS AT INCREASED RISK AND IN NEED OF HIGH RISK SCREENING OR PREVENTION OPTIONS IN THE ABSENCE OF CORRECT INTERPRETATION AND REPORTING OF HER BRCA+ RESULT.

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