BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVS HEALTH AT HOME, COVID-19 TEST KIT

    MDR report key: 19935080 · Received August 7, 2024

    Report

    Report Number
    0002024674-2024-00304
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 7, 2024
    Manufacturer
    QUIDELORTHO 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

    INVESTIGATION CONCLUSION: 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. SOURCE: CONTACT BY PHONE.

    Description of Event or Problem · 0

    CALLER (THE MOM OF THE USER) STATED THEIR DAUGHTER THOUGHT THE SOLUTION TUBE WAS EYEDROP SOLUTION AND PUT DROPS IN HER EYES. THE CALLER SAID THEIR DAUGHTER WAS SICK IN BED BUT DID NOT NOTE IF THIS WAS DUE HER NOT FEELING WELL IN GENERAL OR THIS WAS DUE TO ANY EYE IRRITATION. CALLER WANTED TO KNOW IF THERE WERE HARMFUL CHEMICALS IN THE SOLUTION THAT ARE HARMFUL TO THE EYES. TECHNICAL SUPPORT ASSESSMENT/TROUBLESHOOTING: ADVISED, AS PER THE USER INSTRUCTIONS, THERE ARE CHEMICALS STATED TO BE HARMFUL TO THE EYES AND THEY SHOULD FLUSH WITH WATER. PROVIDED THE WEB ADDRESS FOR QUICKVUEATHOME.COM AND NOTED THAT THE USER INSTRUCTIONS ARE IN THE SUPPORT DOWNLOADABLE RESOURCES SECTION. PROVIDED THE POISON CONTROL NUMBER LISTED IN THE USER INSTRUCTIONS: 800-222-1222.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402773 CVS HEALTH AT HOME, COVID-19 TEST KIT CVS HEALTH AT HOME, COVID-19 TEST KIT QKP QUIDELORTHO CORPORATION NONE 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown