BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERASCREEN® FGFR RGQ RT-PCR KIT

    MDR report key: 15348242 · Received September 2, 2022

    Report

    Report Number
    3004013603-2022-00003
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    July 9, 2022
    Report Date
    September 2, 2022
    Manufacturer
    QIAGEN GMBH
    Product Code
    OWD
    Removal / Correction Number
    Z-1650-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT SUBJECT HAD BEEN ENROLLED INTO A CLINICAL STUDY FOR ERDAFITINIB BASED ON A FALSE POSITIVE RESULT OBTAINED WITH REF: (B)(4) THERASCREEN FGFR RGQ RT- PCR KIT (IUO) AND EXPERIENCED MILD AND MODERATE SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340420 THERASCREEN® FGFR RGQ RT-PCR KIT SOMATIC GENE MUTATION DETECTION SYSTEM OWD QIAGEN GMBH 172016391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other