BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 20006125 · Received August 20, 2024

    Report

    Report Number
    2531491-2024-00082
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR COV3090020 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. TEST RESULTS OF RETENTION SAMPLES FROM COV3090020MET 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. THE FOLLOWING FIELDS ARE UPDATED: B4, "DATE OF THIS REPORT" - DATE OF FOLLOW-UP REPORT. G6, "TYPE OF REPORT" - FOLLOW-UP #1. H2, "IF FOLLOW-UP, WHAT TYPE?" - UPDATED TO "ADDITIONAL INFORMATION" AND "DEVICE EVALUATION" H6 "ADVERSE EVENT PROBLEM" - EVENT PROBLEM AND EVALUATION CODES SUCH AS "INVESTIGATION FINDINGS" AND "INVESTIGATION. CONCLUSIONS" ARE ADDED PER INVESTIGATION. H10 "ADDITIONAL NARRATIVE/DATA" - ADDED MANUFACTURER'S NARRATIVE.

    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

    INVALID RESULTS. WHEN THE CUSTOMER PERFORMED THE 2 TESTS CORRECTLY, NOTHING APPEARED NEXT TO THE "T-LINE", NOTHING APPEARED NEXT TO THE "C-LINE". CUSTOMER PERFORMED THE TEST CORRECTLY WITH 4 DROPS OF THE BUFFER SOLUTION INTO THE S-WELL AND WAITED THE 15 MINUTES. THE CUSTOMER WAS NOT ABLE TO SEND US A PICTURE OF THE 2 TEST CASSETTES.

    Description of Event or Problem · 0

    INVALID RESULTS. WHEN THE CUSTOMER PERFORMED THE 2 TESTS CORRECTLY, NOTHING APPEARED NEXT TO THE "T-LINE", NOTHING APPEARED NEXT TO THE "C-LINE". CUSTOMER PERFORMED THE TEST CORRECTLY WITH 4 DROPS OF THE BUFFER SOLUTION INTO THE S-WELL AND WAITED THE 15 MINUTES. THE CUSTOMER WAS NOT ABLE TO SEND US A PICTURE OF THE 2 TEST CASSETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152117 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV3090020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown