BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 13694963 · Received March 8, 2022

    Report

    Report Number
    0002024674-2022-01079
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    November 26, 2021
    Report Date
    March 8, 2022
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: PROVIDED LOT 801274 IS FOR LIQUID EXTRACTION REAGENT, NOT A QV SARS KIT LOT. A REVIEW OF THE PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. WITHOUT A LOT NUMBER, NO FURTHER INVESTIGATION CAN BE CONDUCTED. INVESTIGATION SUMMARY: PROVIDED LOT 801274 IS FOR LIQUID EXTRACTION REAGENT, NOT A QV SARS KIT LOT, THEREFORE IN RESPONSE TO YOUR COMPLAINT, WE PERFORMED A SEARCH FOR SIMILAR COMPLAINTS OF THE REPORTED PROBLEM. NO ADVERSE TREND WAS OBSERVED. WITHOUT PRODUCT LOT INFORMATION, NO FURTHER TESTING COULD BE CONDUCTED. ALTHOUGH WE WERE UNABLE TO DUPLICATE YOUR COMPLAINT, THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED FALSE POSITIVE RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED NEGATIVE BY MOLECULAR (PCR TESTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260217 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 Unknown