BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12492925 · Received September 17, 2021

    Report

    Report Number
    0002024674-2021-00048
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 17, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUBJECT: OTC CONSUMER STUCK SWAB INTO REAGENT SOLUTION AND THEN UP THEIR NOSE TO SWAB - NO IRRITATION/REACTION - TSS PROVIDED INFORMATION, REFERRED TO PG 5 OF IFU AND TO HEALTHCARE PROVIDER FOR GUIDANCE. INVESTIGATION CONCLUSION: A REVIEW OF THE PACKAGE INSERT (PI) WAS CONDUCTED FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE CUSTOMER?S REPORTED PROBLEM WAS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE PERFORMED A REVIEW OF THE PACKAGE INSERT (PI) FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE REPORTED PROBLEM WE BELIEVE IS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO CORRECT THE PRODUCT CODE TO QKP.

    Description of Event or Problem · 0

    OTC CONSUMER STUCK SWAB INTO REAGENT SOLUTION AND THEN UP THEIR NOSE TO SWAB - NO IRRITATION/REACTION - TSS PROVIDED INFORMATION, REFERRED TO PG 5 OF IFU AND TO HEALTHCARE PROVIDER FOR GUIDANCE.

    Description of Event or Problem · 0

    OTC CONSUMER STUCK SWAB INTO REAGENT SOLUTION AND THEN UP THEIR NOSE TO SWAB - NO IRRITATION/REACTION - TSS PROVIDED INFORMATION, REFERRED TO PG 5 OF IFU AND TO HEALTHCARE PROVIDER FOR GUIDANCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386589 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402 3626537 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1