BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST

    MDR report key: 15391212 · Received September 8, 2022

    Report

    Report Number
    MW5111941
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 6, 2022
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED 8 AT-HOME COVID-19 TEST KITS VIA THE WWW.COVIDTESTS.GOV WEBSITE, DELIVERED ON (B)(6) 2022; ALL ARE MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST KITS, REF 95677, LOT "MB18MAY2202," MANUFACTURE DATE 2022-05-18, USE-BY DATE 2022-11-06; TEST STRIP REFERENCE 87505, LOT 001759-2, EXPIRATION DATE 2022-11-06; SAMPLE BUFFER REF 87506, LOT K0412, EXPIRATION DATE 01/20/2023; STERILE CLEANWIPE FOAM SWAB, REF MP1302ST2, LOT 6869221328, EXPIRATION DATE 2025-02-28. FOLLOWING THE EXACT DIRECTIONS INCLUDED WITH THE TEST KIT, 7 OUT OF THE 8 TESTS YIELDED INVALID TEST RESULTS DUE TO LACK OF A CONTROL LINE. OUT OF THE DOZENS AND DOZENS OF COVID-19 AT-HOME TEST KITS WE HAVE UTILIZED OVER THE PAST FEW YEARS, THESE ARE THE ONLY INVALID RESULTS RECEIVED AND IT IMPLIES THERE WAS SOMETHING WRONG WITH THESE TEST KITS. AFTER THE FAILED TESTS, I RECEIVED A NEGATIVE TEST RESULT WHEN USING AN ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST, REF 195-160, LOT 195031, USE-BY DATE 2023-06-13; TEST STRIP LOT 191169, EXPIRATION DATE 2023-06-13, ADDITIONAL INFORMATION AWLB195430H REV 2/3-1; BINAXNOW COVID-19 AG REAGENT, IDENTIFYING NUMBERS 221091 AND 230624; STERILE CLEANWIPE MEDIUM TIP FOAM SWAB, REF MP1302ST, LOT 6472221020, MANUFACTURER DATE 2022-03-02, EXPIRATION DATE 2025-02-28. AS STATED ABOVE, THE MAXIMBIO COVID-19 AT-HOME TEST KITS DID NOT PROVIDE RESULTS 7 OUT OF 8 TIMES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805346 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202
    1805347 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202
    1805348 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202
    1805349 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202
    1806340 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202
    1806341 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202
    1806342 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB18MAY2202

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male BINAXNOW COVID-19| DAILY MULTIVITAMINS | OMEGA OIL SUPPLEMENTS