BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARDETECT COVID-19 ANTIGEN HOME TEST

    MDR report key: 15327999 · Received August 30, 2022

    Report

    Report Number
    MW5111809
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 29, 2022
    Report Date
    August 29, 2022
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THREE (3) OUT OF 4 COVID TESTS WERE DEFECTIVE (NO CONTROL LINE). MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810055 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB04MAY2203
    1810056 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677
    1810057 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female