BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12334579 · Received August 17, 2021

    Report

    Report Number
    0002024674-2021-00037
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    August 2, 2021
    Report Date
    August 13, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO CORRECT THE PRODUCT CODE TO QKP.

    Description of Event or Problem · 0

    CUSTOMER SWIRLED SWAB IN REAGENT SOLUTION PRIOR TO SWABBING NOSE.

    Additional Manufacturer Narrative · 1

    CUSTOMER SWIRLED SWAB IN REAGENT SOLUTION PRIOR TO SWABBING NOSE. TSS ADVISED CALLING POISON CONTROL AND SEEKING MEDICAL ADVICE. CUSTOMER SEEKING HELP TO REDUCE DISCOMFORT BUT REFUSED TO GIVE DETAILS. CUSTOMER DID NOT PROVIDE LOT NUMBER. INVESTIGATION CONCLUSION CUSTOMER FAILED TO FOLLOW QRI. TSS ADVISED CALLING POISON CONTROL AND SEEKING MEDICAL ADVICE. CUSTOMER REFUSED TO GIVE DETAILS AND HAS NOT RESPONDED TO MULTIPLE ATTEMPTS (3-TO DATE) CONTACT (8/13/2021) TS SUPERVISOR LEFT CONSUMER MESSAGE

    Description of Event or Problem · 1

    CUSTOMER SWIRLED SWAB IN REAGENT SOLUTION PRIOR TO SWABBING NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231983 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR