BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 21313574 · Received February 5, 2025

    Report

    Report Number
    2531491-2025-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    February 3, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QMN
    PMA / PMN Number
    EUA240008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CASE OUTCOME: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR CFL4080001 WERE REVIEWED AND NO ABNORMAL ISSUE WAS FOUND IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS IS COMPLIED WITH DMR. THE TEST RESULTS OF RETENTION SAMPLES FROM CFL4080001 MET THE QC CRITERIA. WE HAVE NOT FOUND THE COMPLAINT ISSUE FROM THE RETAINED CASSETTES. THE COMPLAINT IS NOT VERIFIED. IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION HAS BEEN UPDATED FROM THE INITIAL REPORT UPON COMPLETION OF THE INTERNAL INVESTIGATION: D2 "TYPE OF DEVICE": CORRECTION FOR TYPE OF DEVICE TO QMN. G6 "TYPE OF REPORT": UPDATED TO FOLLOW-UP REPORT #1. H3 "DEVICE EVALUATED BY MANUFACTURER?": DEVICE WAS EVALUATED BY MANUFACTURER. H6 "ADVERSE EVENT PROBLEM": UPDATED FOLLOWING INVESTIGATION OF RETENTION PRODUCT. H10 "ADDITIONAL NARRATIVE/DATA" - UPDATED FOLLOWING INVESTIGATION OUTCOME.

    Additional Manufacturer Narrative · 0

    THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM OUR CONTRACT MANUFACTURER, AND WE WILL PROVIDE FOLLOW UP MDR UPON INVESTIGATION COMPLETION SUCH AS REVIEW OF BATCH RECORDS OR TESTING OF RETENTION SAMPLES. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT. FALSE-NEGATIVE FOR FLU A. THE USER REPORTED THAT THEY TESTED THEIR TWO CHILDREN WITH FLOWFLEX PLUS ON (B)(6) 2025 AND BOTH RESULTS WERE NEGATIVE. THAT SAME MORNING, THEY WENT TO A HEALTHCARE PROVIDER WHERE BOTH CHILDREN WERE TESTED WITH RAPID TESTS AND THE RESULTS WERE POSITIVE FOR FLU A. THE USER CONFIRMED THAT THE FLOWFLEX PLUS TESTS WERE PURCHASED AT (B)(6) PHARMACY.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT. FALSE-NEGATIVE FOR FLU A. THE USER REPORTED THAT THEY TESTED THEIR TWO CHILDREN WITH FLOWFLEX PLUS ON (B)(6) 2025 AND BOTH RESULTS WERE NEGATIVE. THAT SAME MORNING, THEY WENT TO A HEALTHCARE PROVIDER WHERE BOTH CHILDREN WERE TESTED WITH RAPID TESTS AND THE RESULTS WERE POSITIVE FOR FLU A. THE USER CONFIRMED THAT THE FLOWFLEX PLUS TESTS WERE PURCHASED AT WELLCREEK PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60673 FLOWFLEX COVID-19 ANTIGEN HOME TEST COVID-19 MULTI-ANALYTE ANTIGEN DEVICE QMN ACON LABORATORIES, INC. CFL4080001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown