BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21349924 · Received February 10, 2025

    Report

    Report Number
    2531491-2025-00021
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    February 6, 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

    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

    CASE OUTCOME: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR (B)(6) WERE REVIEWED AND NO ABNORMAL ISSUES WERE 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 (B)(6) MET THE QC CRITERIA. THE COMPLAINT ISSUE WAS NOT FOUND 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: D1 "BRAND NAME"/ D2 "TYPE OF DEVICE" - CORRECTION FOR BRAND NAME AND 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.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULTS. CUSTOMER PERFORMED THE TEST KIT ON HIMSELF AND A CHILD. THE TEST RESULTS WERE NEGATIVE FOR COVID FLU A/B FOR THE ADULT AND CHILD. THE CUSTOMER WENT TO DOCTORS' OFFICE SAME DAY, AND BOTH TESTED POSITIVE FOR FLU A. CUSTOMER RETESTED WITH 1 FLOWFLEX PLUS TEST KIT AND RESULT WAS NEGATIVE FOR COVID , FLU A/B. CUSTOMER HAS 1 KIT LEFTOVER AND DOES NOT TRUST THIS BRAND.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULTS. CUSTOMER PERFORMED THE TEST KIT ON HIMSELF AND A CHILD. THE TEST RESULTS WERE NEGATIVE FOR COVID FLU A/B FOR THE ADULT AND CHILD. THE CUSTOMER WENT TO DOCTORS' OFFICE SAME DAY, AND BOTH TESTED POSITIVE FOR FLU A. CUSTOMER RETESTED WITH 1 FLOWFLEX PLUS TEST KIT AND RESULT WAS NEGATIVE FOR COVID , FLU A/B. CUSTOMER HAS 1 KIT LEFTOVER AND DOES NOT TRUST THIS BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870914 FLOWFLEX PLUS COVID-19 AND FLU A/B HOME TEST COVID-19 MULTI-ANALYTE ANTIGEN DEVICE QMN ACON LABORATORIES, INC. CFL4090002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown