BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 16343114 · Received February 9, 2023

    Report

    Report Number
    2531491-2023-00099
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    August 1, 2022
    Report Date
    February 9, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS, FINAL PRODUCT MANUFACTURED, AND QC RECORDS HAVE BEEN REVIEWED FOR LOT COV1110074 AND COV1110218. NO ABNORMAL ISSUE WAS FOUND IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS COMPLIED WITH DMR. TEST RESULTS OF RETENTION SAMPLES FROM COV1110074 AND COV1110218 MEET THE QC CRITERIA. THE COMPLAINT ISSUE WAS NOT FOUND IN THE RETAINED CASSETTES. THE COMPLAINT IS NOT VERIFIED.

    Description of Event or Problem · 0

    FALSE POSITIVE RESULT (S). THE USER STATED THAT: YOUR RAPID TESTING KIT FOR COVID-19 GAVE ME A POSITIVE RESULT 3 TIMES WHEN I PERFORMED IT LAST WEEKEND & TODAY. HOWEVER, WHEN I TESTED USING ANOTHER BRAND'S RAPID TEST AND PCR, THEY BOTH GAVE ME A NEGATIVE RESULT 3 TIMES. FLOWFLEX: (B)(6) 2022: LOT NUMBER 1110074, EXPIRATION DATE: 11/10/2022; (B)(6) 2022: LOT NUMBER 1110218, EXPIRATION DATE: 11/25/2022; (B)(6) 2022: LOT NUMBER 1110218, EXPIRATION DATE: 11/25/2022. BINAXNOW: (B)(6): TESTED NEGATIVE. PCR: (B)(6): TESTED NEGATIVE (RECEIVED RESULTS 24-48 HOURS LATER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607322 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV1110218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown