BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME, COVID-19 TEST KIT

    MDR report key: 19658075 · Received July 2, 2024

    Report

    Report Number
    0002024674-2024-00302
    Event Type
    Injury
    Date Received
    July 2, 2024
    Report Date
    July 2, 2024
    Manufacturer
    QUIDELORTHO CORPORATION .
    Product Code
    QKP
    PMA / PMN Number
    EUA210269/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: CONTACT BY PHONE.

    Description of Event or Problem · 0

    CUSTOMER STATED SHE HAD UNDERLYING HEALTH CONDITIONS THAT MADE HER PRONE TO NOSE BLEED. WHEN SHE SWABBED THE NOSE WITH THE KITTED SWAB, THERE WAS SOME BLOOD ON THE SWAB. CUSTOMER PROCEEDED WITH TESTING AND RECEIVED POSITIVE RESULTS. CUSTOMER ASKED IF BLOOD INTERFERED/CROSS REACTED WITH THE TEST. TECHNICAL SUPPORT ASSESSMENT/TROUBLESHOOTING: PER HCP PACKAGE INSERT, INFORMED CUSTOMER BLOOD UP TO 15% V/V WAS TESTED AND THERE WAS NO INTERFERENCE OR CROSS REACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786132 CVS HEALTH AT HOME, COVID-19 TEST KIT CVS HEALTH AT HOME, COVID-19 TEST KIT QKP QUIDELORTHO CORPORATION . F42130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown