BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 20003787 · Received August 20, 2024

    Report

    Report Number
    2531491-2024-00090
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    August 12, 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

    CUSTOMER SUBMITTED MEDWATCH REPORT (MDR REPORT #MW5158416) PER THE CUSTOMER: "I AM IMMUNOSUPPRESSED. THANK GOODNESS I HAD THE THIRD KIT BECAUSE I AM NOW ON PAXLOVID AND IN THE MIDDLE OF COVID" ATTACHED IS THE COMPLETE REPORT FOR REFERENCE, OUR FINDING INDICATES THAT THE PRODUCT IS COUNTERFEIT, BUT NO INJURY WAS REPORTED. 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. E4, "INITIAL REPORTER" - INITIAL REPORTER ALSO SENT THE REPORT TO FDA. G6, "TYPE OF REPORT" - FOLLOW-UP #1. H2, "IF FOLLOW-UP, WHAT TYPE?" - UPDATED TO "ADDITIONAL INFORMATION". 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 RESULT (S). WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH 4 FLOWFLEX COVID 19 ANTIGEN TEST KIT. THE CUSTOMER JUST PURCHASED THE 4 TEST KITS FROM INVARA PHARMACY , SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE 2 TESTS CORRECTLY, CUSTOMER GOT A FAINT LINE NEXT TO THE T-LINE ONLY, NOTHING NEXT TO THE C-LINE. CUSTOMER PERFORMED THE 2 TESTS CORRECTLY WITH 4 DROPS OF THE BUFFER SOLUTION INTO THE S-WELL AND WAITED THE 15 MINUTES. THE CUSTOMER HAS 2 TESTS LEFT OF THE SAME LOT NUMBER, AND IS REQUESTING THE KITS BE REPLACED, HE IS NOT GOING TO USE THEM DUE TO BEING IMMUNE COMPROMISED. CUSTOMER PURCHASED A KIT FORM A DIFFERENT LOT NUMBER (COV3090015 ) AND THAT TEST WORKED WITHOUT ISSUE. I ADVISED THE CUSTOMER THAT I WILL BE FORWARDING THE INFORMATION TO THE COMPLAINT TEAM FOR REVIEW

    Description of Event or Problem · 0

    INVALID RESULT (S). WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH 4 FLOWFLEX COVID 19 ANTIGEN TEST KIT. THE CUSTOMER JUST PURCHASED THE 4 TEST KITS FROM (B)(4) PHARMACY, SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE 2 TESTS CORRECTLY, CUSTOMER GOT A FAINT LINE NEXT TO THE T-LINE ONLY, NOTHING NEXT TO THE C-LINE. CUSTOMER PERFORMED THE 2 TESTS CORRECTLY WITH 4 DROPS OF THE BUFFER SOLUTION INTO THE S-WELL AND WAITED THE 15 MINUTES. THE CUSTOMER HAS 2 TESTS LEFT OF THE SAME LOT NUMBER, AND IS REQUESTING THE KITS BE REPLACED, HE IS NOT GOING TO USE THEM DUE TO BEING IMMUNE COMPROMISED. CUSTOMER PURCHASED A KIT FORM A DIFFERENT LOT NUMBER (COV3090015) AND THAT TEST WORKED WITHOUT ISSUE. I ADVISED THE CUSTOMER THAT I WILL BE FORWARDING THE INFORMATION TO THE COMPLAINT TEAM FOR REVIEW

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403361 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV3090005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown