BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 16306025 · Received February 6, 2023

    Report

    Report Number
    2531491-2023-00015
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    December 27, 2021
    Report Date
    February 6, 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

    NO ABNORMAL ISSUE WAS FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS. THE TEST RESULTS OF RETENTION SAMPLES OF COV1100088 MET THE QC CRITERIA. THE COMPLAINT ISSUE WAS NOT REPRODUCED WITH THE RETENTION SAMPLES. THE ROOT CAUSE IS UNDETERMINED. SIMILAR ISSUES WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    FALSE POSITIVE RESULT(S). CUSTOMER STATED THAT THEY RECEIVED POSITIVE RESULTS USING FF AND NEGATIVE RESULTS FROM A LAB TEST. USER STATED THAT THEY PURCHASED THE KIT FROM A WALGREENS IN GA. I WILL REACH OUT TO THE CUSTOMER TO ASK IF THEY'D LIKE REPLACEMENT KITS, BUT BASED ON THEIR EMAIL, THAT SEEMS UNLIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113885 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV1100088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other