BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTART COVID 19 HOME TEST

    MDR report key: 18382793 · Received December 21, 2023

    Report

    Report Number
    MW5149449
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 19, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ACCESS BIO, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COVID TEST MADE BY ACCESS BIO. THE SAMPLE LINE DID NOT MOVE CORRECTLY DOWN TEST STRIP LEADING TO INCONCLUSIVE RESULTS. THIS HAPPENED WITH TWO DIFFERENT TESTS WITHIN 24 HOURS. SEE UPLOADED PICTURES. REFERENCE REPORT: #MW5149450. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262952 CARESTART COVID 19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESS BIO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female