BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVS HEALTH AT HOME, COVID-19 TEST KIT

    MDR report key: 19899514 · Received August 2, 2024

    Report

    Report Number
    0002024674-2024-00303
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 2, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QKP
    PMA / PMN Number
    EUA210269
    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

    CONSUMER REPORTING THE COLLECTION SWAB HAS SOME BLOOD ON IT AFTER SWABBING 1 NOSTRIL. CONSUMER STATED THEY HAVE BEEN SNEEZING AND BLOWING THEIR NOSE FREQUENTLY, BUT THE TISSUES NEVER HAD BLOOD ON THEM. CONSUMER STATED THEY ARE NOT ACTIVELY BLEEDING FROM THE NOSE; IT MUST BE IRRITATED FROM ALL OF THE SNEEZING AND NOSE BLOWING. HOW MUCH BLOOD IS ON THE SWABS HEAD? - HALF OF THE SWAB HEAD HAS BLOOD ON IT.-HOW FAR INTO YOUR NOSE DID YOU INSERT THE SWAB? - ABOUT 3/4 LIKE THE DIRECTIONS SAY, IT DIDN'T SEEM TOO FAR INSIDE. DO YOU HAVE ANOTHER COLLECTION SWAB AVAILABLE IN THE KIT? - YES. TECHNICAL SUPPORT ASSESSMENT/TROUBLESHOOTING: INFORMED CUSTOMER A BLOODY SWAB SHOULD NOT BE USED FOR TESTING. ADVISED WAITING TILL THE MILD BLEEDING INSIDE HAS STOPPED, NOT INSERTING TOO FAR INSIDE OR RUBBING THE SWAB TOO HARD DURING COLLECTION. INFORMED CUSTOMER THAT Q-TIPS ARE NOT ACCEPTABLE FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375510 CVS HEALTH AT HOME, COVID-19 TEST KIT CVS HEALTH AT HOME, COVID-19 TEST KIT QKP QUIDELORTHO CORPORATION 2310005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown