BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 20287118 · Received September 23, 2024

    Report

    Report Number
    2531491-2024-00133
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 20, 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 COV3129001 WERE REVIEWED AND IT WAS DETERMINED THAT THE ISSUE IS NOT PRESENT ON ANY OTHER PRODUCT AND THE PRODUCT WAS CONSIDERED ACCEPTABLE. ACCORDING TO THE RECORDS REVIEWED, THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. NO ISSUES HAVE BEEN DETECTED DURING THE MANUFACTURING PROCESS AND QUALITY CONTROL INSPECTION AND THE MANUFACTURING PROCESS COMPLIES WITH THE SOP. RETENTION SAMPLES FROM COV3129001 WERE TESTED AND NO DEFECTS WERE OBSERVED.IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION HAS BEEN UPDATED FROM THE INITIAL REPORT UPON COMPLETION OF THE INTERNALINVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO L/N OR CONTACT INFO WAS PROVIDED: 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. WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH A FLOWFLEX COVID 19 ANTIGEN TEST KIT. THE CUSTOMER JUST PURCHASED THE TEST KIT FROM RITE AID, SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY, THE TEST CASSETTE SHOWED NOTHING NEXT TO THE T-LINE, AND NOTHING NEXT TO THE C-LINE. THE CUSTOMER WAS ABLE TO SEND US A PICTURE. I ADVISED THE CUSTOMER THAT I WILL BE FORWARDING THE INFORMATION TO THE COMPLAINT TEAM FOR REVIEW. CUSTOMER WILL AWAIT AN EMAIL BACK FROM ACON LABS.

    Description of Event or Problem · 0

    INVALID RESULT. WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH A FLOWFLEX COVID 19 ANTIGEN TEST KIT. THE CUSTOMER JUST PURCHASED THE TEST KIT FROM RITE AID, SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY, THE TEST CASSETTE SHOWED NOTHING NEXT TO THE T-LINE, AND NOTHING NEXT TO THE C-LINE. THE CUSTOMER WAS ABLE TO SEND US A PICTURE. I ADVISED THE CUSTOMER THAT I WILL BE FORWARDING THE INFORMATION TO THE COMPLAINT TEAM FOR REVIEW. CUSTOMER WILL AWAIT AN EMAIL BACK FROM ACON LABS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138801 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV3129001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown