BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX PLUS COVID-19 AND FLU A/B HOME TEST

    MDR report key: 20844751 · Received December 4, 2024

    Report

    Report Number
    2531491-2024-00172
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    December 2, 2024
    Report Date
    May 6, 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

    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.

    Additional Manufacturer Narrative · 0

    FINAL PRODUCT MANUFACTURE AND QC RECORD FOR CFL4080007 WERE REVIEWED AND NO ISSUE WAS FOUND IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS COMPLIED WITH THE DMR. THE TEST RESULTS OF RETENTION SAMPLES FROM CFL4080007 MEET THE QC CRITERIA. THE COMPLAINT ISSUE WAS NOT FOUND WITH THE RETAINED CASSETTES. THE COMPLAINT IS NOT VERIFIED. THE FOLLOWING FIELDS ARE UPDATED: B4, "DATE OF THIS REPORT" - DATE OF THIS FOLLOW-UP REPORT. D1, FLOWFLEX COVID-19 ANTIGEN HOME TEST WAS CHANGED TO FLOWFLEX PLUS COVID-19 AND FLU A/B HOME TEST. D2, WAS CHANGED FROM QKP TO QMN. D3, ADDRESS WAS CHANGED TO (B)(6). G1, CONTACT OFFICE AND PERSONNEL WERE REVISED. G4, WAS CHANGED TO (B)(4). G6, "TYPE OF REPORT" - FOLLOW-UP #1. H2, "IF FOLLOW-UP, WHAT TYPE?" - ADDED "ADDITIONAL INFORMATION" AND "DEVICE EVALUATION". H3: RETENTION LOT WAS EVALUATED. H6 "ADVERSE EVENT PROBLEM" - EVENT PROBLEM AND EVALUATION CODES ARE UPDATED FOR "TYPE OF INVESTIGATION (B)", "INVESTIGATION FINDINGS (C)" AND "INVESTIGATION CONCLUSIONS (D)" PER THE INVESTIGATION. H11 "ADDITIONAL NARRATIVE/DATA" - UPDATED MANUFACTURER'S NARRATIVE.

    Description of Event or Problem · 0

    INVALID RESULT. THE DYE RUNS, MAKING IT IMPOSSIBLE TO TELL IF IT'S POSITIVE OR JUST THE DYE RUNNING, I FOLLOWED THE DIRECTIONS PERFECTLY, AND I DIDN'T OVER SATURATE THE TEST WITH LIQUID.

    Description of Event or Problem · 0

    INVALID RESULT. THE DYE RUNS, MAKING IT IMPOSSIBLE TO TELL IF IT'S POSITIVE OR JUST THE DYE RUNNING, I FOLLOWED THE DIRECTIONS PERFECTLY, AND I DIDN'T OVER SATURATE THE TEST WITH LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108785 FLOWFLEX PLUS COVID-19 AND FLU A/B HOME TEST COVID 19 MULTI-ANALYTE ANTIGEN DEVICE, PRODUCT CODE: QMN QMN ACON LABORATORIES, INC. CFL4080007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown