BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 17086958 · Received June 8, 2023

    Report

    Report Number
    2531491-2023-00574
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 4, 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 WERE REVIEWED FOR LOT COV2030005. NO ABNORMAL ISSUE WAS FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING, AND QUALITY CONTROL INSPECTION, THE MANUFACTURING PROCESS COMPLIED WITH THE DMR. TEST RESULTS OF RETENTION SAMPLES MEET THE QC CRITERIA. THE REPORTED ISSUE WAS NOT FOUND. COMPLAINT IS NOT VERIFIED.

    Description of Event or Problem · 0

    FALSE POSITIVE RESULT (S). (B)(6) DOB 10/20/1945 WAS SCHEDULED FOR SURGERY AT (B)(6). ON (B)(6) 2023. SHE WAS ADMINISTERED A FLOWFLEX ANTIGEN TEST AT THAT TIME AND TESTED POSITIVE. WE RETURNED TO MAINE AND TOOK A HOME ANTIGEN TEST FROM IHEALTH. BOTH OF US TESTED NEGATIVE. WE THEN WENT TO CVS AND HAD AN ANTIGEN TEST DONE BY THE ATTENDING NURSE. BOTH CAME BACK NEGATIVE. A SAMPLE WAS ALSO SENT TO A LAB FOR A PCR TEST. BOTH CAME BACK NEGATIVE. THIS WAS ALL DONE (B)(6) 2023. ON 3/7/2023 A FLOWFLEX TEST KIT WAS PURCHASED FROM CVS ON (B)(6). (B)(6) DID A HOME TEST THAT DAY. IT CAME BACK POSITIVE. LOT # COV2030005. NONE OF THE ANTIGEN TEST RESULTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289644 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV2030005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown