BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATERNIT21

    MDR report key: 2903746 · Received January 2, 2013

    Report

    Report Number
    MW5028444
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    March 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    SEQUENOM
    Product Code
    OQS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GAVE BIRTH WITH A SURPRISE DIAGNOSIS OF TRISOMY 21, DOWN SYNDROME. ON (B)(6) 2012 I PARTICIPATED IN A TEST CALLED MATERNIT21 BY A COMPANY NAMED SEQUENOM. ACCORDING TO THE TEST RESULTS MY SON WAS NEGATIVE FOR DOWN SYNDROME THROUGH THE FETAL CHROMOSOME TEST HOWEVER, AT BIRTH THE DIAGNOSIS WAS CONFIRMED. THE INITIAL TEST WAS CONDUCTED ON (B)(6) 2012 WITH AN ESTIMATED FRAME OF 5 BUSINESS DAYS. MY GENETIC COUNSELOR REACHED OUT TO SEQUENOM AND INQUIRED ABOUT THE DELAY IN TEST RESULTS. SEQUENOM'S RESPONSE TO THE DELAY WAS "IT DID NOT WORK" AND THEY WOULD REDO THE TEST UTILIZING THE SAME BLOOD SAMPLE. FOUR DAYS AFTER THE INITIAL TEST RESULTS, I WAS GIVEN A "NEGATIVE" RESULT OF TRISOMY 21, 13 AND 18. THOSE RESULTS WERE NOT CORRECT. I HAVE MADE SEVERAL OUTREACH CALLS TO SEQUENOM TO SPEAK WITH ONE OF THEIR COUNSELORS IN REGARDS TO THE ERROR SEVERAL TIMES AND TO NOTIFY THEM OF THEIR INACCURACY AND AS OF TODAY, THEY HAVE FAILED TO RESPOND OR ACKNOWLEDGE. THEY HAVE NOT CHANGED THEIR STATISTICS ON THEIR WEBSITE AND THEY HAVE NOT REPORTED THEIR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329 MATERNIT21 NONE OQS SEQUENOM

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability