BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST

    MDR report key: 15391233 · Received September 8, 2022

    Report

    Report Number
    MW5111942
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    September 3, 2022
    Report Date
    September 7, 2022
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EIGHT MAXIMBIO COVID TESTS FROM LOT MB10MAY2203 GAVE WHAT I BELIEVE TO BE FALSE POSITIVE TEST RESULTS. FEELING COLD SYMPTOMS, MY PARTNER AND I USED A MAXIMBIO AT-HOME COVID-19 TEST, AND BOTH TESTED POSITIVE. SUBSEQUENTLY WE SCHEDULED A PCR TEST, ENTERED ISOLATION AND CANCELED WORK AND A PLANNED VACATION. FROM SATURDAY (B)(6) TO WEDNESDAY (B)(6) 2022 WE BOTH TESTED DAILY, AND KEPT TESTING POSITIVE ON MAXIMBIO TESTS¿BUT NEGATIVE ON FLOWFLEX AND ABBOTT BINAXNOW. WE BOTH RECEIVED NEGATIVE PCR RESULTS ON WEDNESDAY (B)(6). SUSPICIOUS OF THE TEST RESULT, WE RE-TESTED WITH OUR MAXIMBIO TESTS AND RECEIVED A POSITIVE RESULT. THESE AT-HOME TESTS ALL COME FROM LOT MB10MAY2203, WITH MANUFACTURE DATES OF MAY 10, 2022 AND EXPIRATION DATES OF OCTOBER 28, 2022, AND WERE ORDERED AND DELIVERED VIA USPS. IN TOTAL, EIGHT MAXIMBIO TESTS WERE USED, ALL OF WHICH GAVE POSITIVE RESULTS; WE ALSO USED ONE ABBOT BINAXNOW AND FOUR FLOWFLEX AT-HOME TESTS, WHICH ALL GAVE NEGATIVE RESULTS, AS DID OUR PCR TESTS ADMINISTERED BY (B)(6) MEDICAL CENTER IN (B)(6). ALL MAXIMBIO TESTS WERE POSITIVE; PCR, ABBOT BINAXNOW, AND FLOWFLEX WERE ALL NEGATIVE. THESE MAXIMBIO TESTS ARE ALL FROM THE SAME LOT NUMBER, BUT DIFFERENT BOXES, AND ARE BEING USED BEFORE THEIR EXPIRATION. ALL CAME FROM THE USPS'S RECENT FREE AT-HOME COVID TEST PROGRAM OVER THE SUMMER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806343 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806344 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806345 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806346 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806347 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806348 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806349 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203
    1806350 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB10MAY2203

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other ABBOT BINAXNOW COVID ANTIGEN TEST| FLOWFLEX COVID ANTIGEN TEST| PCR TEST