BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOMAL DNA TEST

    MDR report key: 10801147 · Received November 5, 2020

    Report

    Report Number
    MW5097692
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    February 9, 2019
    Report Date
    November 5, 2020
    Manufacturer
    UNK
    Product Code
    PKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED HE HAD A DNA TEST DONE USING THE AUTOSOMAL DNA TEST AT (B)(6) AND BELIEVED THE TEST IS FAKE. HE ALSO BELIEVED IT IS NOT A REAL TEST, DONE THROUGH THE COURTS BY (B)(6). REPORTER STATED THAT (B)(6) CLAIMS THAT A MOTHER'S DNA IS OPTIONAL (IN (B)(6) WEBSITE) BUT THREE VARIABLES ARE REQUIRED FOR THE DNA AUTOSOMAL TEST; THE MOTHER, THE CHILD, AND THE PROSPECTIVE FATHER. (B)(6) IS ONLY TESTING THE CHILD AND FATHER AND NOT USING THE MOTHER'S DNA, WHICH IS NOT HOW AN AUTOSOMAL TEST IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254998 AUTOSOMAL DNA TEST AUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM PKB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention