BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENETIC TESTING

    MDR report key: 15771529 · Received November 9, 2022

    Report

    Report Number
    MW5113216
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    August 8, 2022
    Report Date
    November 8, 2022
    Manufacturer
    UNK
    Product Code
    PJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SEQUENCING.COM GAVE ME A TEST RESULTS OF POSITIVE FOR THE BRCA2 GENE MUTATION DELETION AND INCREASED RISK OF BREAST CANCER. MY PHYSICIAN DID CONFIRMATORY TESTING WITH ANOTHER COMPANY, SENT ME FOR A BREAST MRI, BREAST SPECIALIST AND GENETIC COUNSELOR. AFTER I PAID FOR ALL OF THESE TESTS AND WAS GOING TO BE SCHEDULED FOR A DOUBLE MASTECTOMY, SEQUENCING.COM CHANGED MY RESULTS TO NEGATIVE. THIS OCCURRED OVER 2 MONTHS TIME DURING WHICH I SUFFERED GREAT EMOTIONAL AND PHYSICAL STRESS WHICH CAUSED MY AUTOIMMUNE DISEASES TO FLARE. THEY WERE GROSSLY NEGLIGENT. SEQUENCING.COM IS A SCAM THAT HURTS PEOPLE. THEY PROMOTE THE HEALTHCARE PRO APP REPORT AS BEING CONFIGURED TO GIVE TO YOUR PHYSICIAN FOR TREATMENT, WHICH I DID. CUSTOMER SERVICE THEN QUOTES THE DISCLAIMER THAT SAYS IT IS NOT. THE EXACT WORDING THEY USE IS "PROVIDES A GENETIC REPORT DESIGNED FOR HEALTHCARE PROFESSIONALS." THIS IS NOW PART OF MY MEDICAL RECORD AND CANNOT BE UNDONE. OVERALL, THEY MANIPULATED AT LEAST 2 OF MY REPORTS MULTIPLE TIMES, CHANGING MY RESULTS MULTIPLE TIMES AFTER IT WAS SHARED WITH 3 PHYSICIANS AND THEY ORDERED TESTING AND TREATMENT BECAUSE OF IT. I'M OUT (B)(6) AND THERE IS NO ACCOUNTABILITY HERE. PLEASE HELP. OTHER WOMEN MAY HAVE HAD THEIR BREASTS REMOVED FOR NO REASON, THANK GOODNESS MY DR WAS WISE ENOUGH TO RETEST ME TO MAKE SURE. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/17/2022 FOR REPORT MW5113216 TO UPDATE PROCODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372001 GENETIC TESTING CANCER-RELATED GERMLINE GENE MUTATION DETECTION SYSTEM PJG UNK
    1416365 GENETIC TESTING CANCER-RELATED GERMLINE GENE MUTATION DETECTION SYSTEM PJG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other