BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 14325670 · Received May 7, 2022

    Report

    Report Number
    2531491-2022-00007
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    March 6, 2022
    Report Date
    April 28, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION IS DIFFERENT FROM THE INITIAL REPORT AS NEW INFORMATION REGARDING PATIENT HEALTH WAS RECEIVED. B5: DESRIBE EVENT OR PROBLEM. G7: TYPE OF REPORT. H2: IF FOLLOW-UP, WHAT TYPE? H6: EVENT PROBLEM AND EVALUATION CODES.

    Description of Event or Problem · 0

    TREATMENT IS TIME SENSITIVE. DEVELOPED SORE THROAT AND COUGH SYMPTOMS. TOOK 2 AT HOME COVID TESTS FROM FLOW FLEX. 24 HOURS APART. FOLLOWED DIRECTIONS, BOTH CAME OUT NEGATIVE, IN SPITE OF FAINTNESS AND FATIGUE SYMPTOMS ON THE SECOND DAY. NEXT DAY WENT TO URGENT CARE FOR TESTING BECAUSE I AM 22 WEEKS PREGNANT AND THE RAPID ANTIGEN TEST WAS ALSO NEGATIVE, BUT THE PCR CAME OUT POSITIVE. FRIEND TOLD ME AFTERWARDS THAT FLOW FLEX TESTS HAD A BAD REPUTATION, BUT THEY WERE THE ONLY ONES COVERED BY MY INSURANCE (B)(6) WHEN I BOUGHT THEM FOR HOME USE. FDA SAFETY REPORT ID# (B)(4). REFER TO: MW5108021.

    Description of Event or Problem · 0

    BATCH RECORDS FOR FINAL PRODUCT MANUFACTURING AND QC RECORDS FOR COV1120162 WERE REVIEWED AND NO ABNORMAL ISSUE WAS FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS. THE TEST RESULTS OF RETAINED SAMPLES OF COV1120162 MET THE QC CRITERIA. THE COMPLAINT ISSUE WAS NOT FOUND WITH THE RETAINED CASSETTES. THE ROOT CAUSE IS UNDERTERMINED. SIMILAR ISSUES WILL BE TRACKED AND TRENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722585 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. L031-118B5 COV1120162

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization