BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE COVID TEST PI ONLINE WITH FDA

    MDR report key: 12779240 · Received November 8, 2021

    Report

    Report Number
    MW5105166
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 3, 2021
    Manufacturer
    QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USING THE QUICKVUE RAPID AT HOME COVID TEST. FOLLOWED DIRECTIONS ONLINE, GFS. THERE IS A TYPO IN THE NEGATIVE TEST RESULTS SECTION! TYPO IS 'NOTE'. SHOULD SAY NOT DETECTED; (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665229 QUICKVUE COVID TEST PI ONLINE WITH FDA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown