BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDICAID OTC COVID-19 RAPID ANTIGEN AT-HOME TEST

    MDR report key: 19772553 · Received July 17, 2024

    Report

    Report Number
    MW5157361
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    July 4, 2024
    Report Date
    July 14, 2024
    Manufacturer
    PHASE SCIENTIFIC INTERNATIONAL LIMITED
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SCRATCHY THROAT MORNING OF (B)(6) 2024, TOOK AT HOME COVID TEST, IT WAS NEGATIVE. SYMPTOMS CONTINUE TO WORSEN ON (B)(6), TOOK AT HOME COVID TEST, IT WAS NEGATIVE. SYMPTOMS CONTINUED TO WORSEN ON (B)(6), TOOK AT HOME COVID TEST IT WAS NEGATIVE. MORNING OF (B)(6) 2024, COVID TEST AT DOCTOR'S OFFICE WAS POSITIVE, STARTED PAXLOVID. SYMPTOMS SEEM TO HAVE RESOLVED ON (B)(6) 2024, TOOK AT HOME COVID TEST, IT WAS NEGATIVE. UNKNOWN STATUS OF MY COVID19 INFECTION DUE TO REPEATED FALSE NEGATIVE RESULTS OF AT HOME TESTING. REFERENCE REPORTS MW5157359, MW5157360, MW5157362.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220975 INDICAID OTC COVID-19 RAPID ANTIGEN AT-HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP PHASE SCIENTIFIC INTERNATIONAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other CENTRUM SILVER MULTIVITAMIN| LEVOTHYROXINE (B)(6) 2024| PAXLOVID (B)(6) 2024| VITAMIN D