BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASCREEN EGFR RGQ PCR KIT

    MDR report key: 9845343 · Received March 17, 2020

    Report

    Report Number
    3004013603-2020-00001
    Event Type
    Injury
    Date Received
    March 17, 2020
    Report Date
    March 17, 2020
    Manufacturer
    QIAGEN GMBH
    Product Code
    OWD
    UDI-DI
    04053228002062
    PMA / PMN Number
    P120022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO INJURY WAS REPORTED, A FALSE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND COULD CAUSE INJURY TO THE PATIENT. QIAGEN IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION. QIAGEN DOES NOT KNOW HOW THE RESULT WAS USED TO GUIDE THE PATIENT'S TREATMENT OR THE STATUS OF THE PATIENT.

    Description of Event or Problem · 1

    CUSTOMER OBTAINED A FALSE POSITIVE G719X RESULT USING THE TEST AND REPORTED IT TO THE PHYSICIAN. TREATMENT AND STATUS OF PATIENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308699 THERASCREEN EGFR RGQ PCR KIT THERASCREEN EGFR RGQ PCR KIT OWD QIAGEN GMBH 1 163035334 04053228002062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other