BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 19726606 · Received July 11, 2024

    Report

    Report Number
    2531491-2024-00065
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 10, 2024
    Report Date
    July 11, 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

    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

    THIS IS THE THREE HUNDRED AND EIGHTY-SECOND OF THE SIMILAR ISSUE (COVID-19 ANTIGEN HOME TEST, INVALID RESULT, AND ROOT CAUSE UNKNOWN) DURING THE PAST TWO YEARS. BASED ON THE REPORTED QTY. OF COMPLAINTS AND SALES VOLUME OF THE PRODUCT IN THE LAST TWO YEARS, THE CALCULATED COMPLAINT RATE IS (B)(4). SO THE FREQUENCY IS REMOTE. 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.

    Description of Event or Problem · 0

    INVALID RESULT. INVALID RESULT. THE USER CONFIRMED THAT THEY PERFORMED THE TEST PROCEDURE CORRECTLY BUT THEIR TEST CASSETTE DIDN'T PRODUCE A CONTROL (C) OR TEST (T) LINE.

    Description of Event or Problem · 0

    INVALID RESULT. INVALID RESULT. THE USER CONFIRMED THAT THEY PERFORMED THE TEST PROCEDURE CORRECTLY BUT THEIR TEST CASSETTE DIDN'T PRODUCE A CONTROL (C) OR TEST (T) LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315924 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV3090018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown