BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALGREENS COVID-19 & FLU A + B ANTIGEN TEST

    MDR report key: 22788032 · Received August 12, 2025

    Report

    Report Number
    3009238284-2025-00001
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 11, 2025
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    SCA
    PMA / PMN Number
    DEN240029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. THE INVESTIGATION USED RETAINED SAMPLES OF THE LOT IN USE AT THE TIME OF THE EVENT. WHEN TESTED NO IRREGULARITIES WERE OBSERVED. ALL DEVICES PERFORMED AS EXPECTED WHEN TESTED PER THE STANDARD PROCEDURE. NO PRODUCT PROBLEM IDENTIFIED, THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    THE COMPLAINT INVOLVES A CUSTOMER REPORT OF AN INVALID TEST RESULT, INDICATED BY THE ABSENCE OF CONTROL LINES IN BOTH RESULT WINDOWS. THE COMPLAINANT STATED THAT A PORTION OF THE SPECIMEN OVERFLOWED THE SAMPLE WELL DUE TO RAPID ADDITION OF THE SAMPLE. INSTEAD OF PERFORMING REPEAT TESTING WITH A NEW SPECIMEN AND TEST KIT, AS RECOMMENDED IN THE QUICK REFERENCE INSTRUCTIONS (QRI) FOR ANY INVALID RESULT, THE COMPLAINANT ADDED AN ADDITIONAL 8 DROPS OF SAMPLE TO THE SAME USED TEST CASSETTE, WHICH AGAIN PRODUCED AN INVALID RESULT, AS EXPECTED. THE FOLLOWING DAY, THE PATIENT REPORTEDLY TESTED POSITIVE AT A DOCTOR'S OFFICE; HOWEVER, NO INFORMATION WAS PROVIDED REGARDING THE TESTING METHODOLOGY USED AT THAT FACILITY. THERE WERE NO REPORTS OR ALLEGATIONS OF ANY ADVERSE EVENT ASSOCIATED WITH THE INVALID TEST RESULT. THE LOT NUMBER REPORTED TO THE MANUFACTURER WAS 2503179 DEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563097 WALGREENS COVID-19 & FLU A + B ANTIGEN TEST MULTI-ANALYTE RESPIRATORY VIRUS ANTIGEN DETECTION TEST SCA HEALGEN SCIENTIFIC LLC 2503179DEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male