BEUDAMED
    FDA Adverse Event Other Summary report: N

    BABY GENDER MENTOR TEST

    MDR report key: 747091 · Received October 29, 2005

    Report

    Report Number
    MW1037898
    Event Type
    Other
    Date Received
    October 29, 2005
    Date of Event
    August 5, 2005
    Report Date
    October 29, 2005
    Manufacturer
    ACU-GEN LAB
    Product Code
    LIM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER'S DAUGHTER PURCHASED THE BABY GENDER MENTOR TEST FROM ACU-GEN LAB. INSTEAD OF THE TECH CALLING TO CONFIRM THAT SHE WAS HAVING A BOY OR GIRL, THEY DIAGNOSED HER BABY, OVER THE PHONE, WITH CHROMOSONAL ABNORMALITIES. THIS TYPE OF TESTING WAS NOT SUPPOSED TO BE DONE WITH HER BLOOD SAMPLE, NOR SHOULD SHE HAVE BEEN NOTIFIED BY A COMPLETE STRANGER, WHO CLAIMS TO BE A DR, VIA TELEPHONE, TO BE TOLD SOMETHING OF THIS NATURE. THE ADVERTISEMENT FOR THIS TEST, ONLY STATES THAT THEY WILL CHECK FOR THE BABIE'S "GENDER", NOTHING ELSE. REPORTER'S DAUGHTER'S OB DR HAS DONE TESTS AT THE CORRECT TIME, FOR "RELIABLE" RESULTS, AND HAS FOUND NOTHING WHATEVER WRONG WITH HER BABY TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY GENDER MENTOR TEST GENDER FINDING BLOOD TEST LIM ACU-GEN LAB UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other