BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTART COVID 19 ANTIGEN HOMETEST

    MDR report key: 18463911 · Received January 5, 2024

    Report

    Report Number
    MW5149887
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 4, 2024
    Manufacturer
    ACCESSBIO / ACCESS BIO INCORPORATE
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CARESTART COVID 19 HOME TEST DID NOT WORK PROPERLY. ALL DIRECTIONS WERE FOLLOWED CAREFULLY BUT THE SPECIMEN DID NOT MIGRATE UP TO THE CONTROL LINE ON THE TEST PANEL AND BOTH TEST AND CONTROL LINES WERE NEGATIVE (ABSENT.) TEST REPEATED WITH SECOND TEST APPARATUS FROM SAME BOX AND CONTROL WAS POSITIVE AND TEST WAS NEGATIVE. OF NOTE, I ADDED FOUR DROPS THE SECOND TIME RATHER THAN 3 AS ADVISED IN THE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599922 CARESTART COVID 19 ANTIGEN HOMETEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESSBIO / ACCESS BIO INCORPORATE CP22M12

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male ACETAMINOPHEN| INSULIN