BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 17087591 · Received June 8, 2023

    Report

    Report Number
    2531491-2023-00580
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    April 14, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BACTH RECORDS FOR (B)(6) WERE REVIEWED AND NO ABNORMAL ISSUE WAS FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS WAS COMPLIED WITH THE DMR. THE BATCHES OF BUFFER USED IN THIS BATCH PRODUCT WERE AS FOLLOW: 220218-C3867-308(220209009), 220221-C3867-442(220214003), 220222-C3867-458(220215006); 220224-C3867-419(220215003), 220224-C3867-420(220215003), 220224-C3867-421(220215003); 220225-C3867-422(220209003), 220225-C3867-425(220208004), 220225-C3867-427(220209007); 220225-C3867-428(220209002), 220225-C3867-428(220209002), 220225-C3867-429(220209002); 220225-C3867-429(220209002), 220225-C3867-430(220209008), 220225-C3867-431(220210004); 220225-C3867-434(220204008), 220225-C3867-436(220204008), 220225-C3867-437(220208007); 220225-C3867-438(220206002), 220225-C3867-442(220209008), 220225-C3867-448(220204008); 220228-C3867-309(220221004), 220228-C3867-310(220221004). RETENTION SAMPLES FROM THE REPORTED BATCH WERE CHECKED, NO RELATED ISSUES WERE FOUND, AND ALL BUFFER TUBES WERE NORMAL. BASED ON THE CUSTOMER'S FEEDBACK, THE SUPPLIER CONDUCTED AN INVESTIGATION ON THE 14 POSSIBLE BATCHES OF EXTRACTION BUFFER USED. THEY REVIEWED THE PRODUCTION RECORDS FOR THAT 14 BATCHES AND ALL OF THEM WERE PRODUCED IN FEBRUARY 2022. HOWEVER, ON FEBRUARY 2, 2023, IMPROVEMENT MEASURES HAD BEEN TAKEN TO ADDRESS THE ISSUE OF POSSIBLE INSECTS IN THE BUFFER TUBE. SUPPLIER'S DETAILED ANALYSIS WAS AS FOLLOWS: 1) THE FILLING WORKSHOP WAS A CLEAN WORKSHOP, AND THERE WERE MOSQUITO CONTROL LAMPS BEING TURNED ON ALL DAY FOR PEST CONTROLS, REDUCING THE POSSIBILITY OF FLYING INSECTS ENTERING. 2) IN THE INJECTION MOLDING WORKSHOP, IF THE OPERATOR FAILED TO SEAL THE PRODUCT IN A TIMELY MANNER, IT MAY CAUSE FLYING INSECTS TO ENTER INSIDE. 3) THE INSPECTOR DID NOT IDENTIFY THE DEFECTIVE ONE. SUPPLIER PREVENTIVE AND CORRECTIVE MEASURES ARE AS FOLLOW: 1) DRAFT THE QUALITY ALERT AND ISSUE A WARNING TO THE WORKSHOP. 2) TRAIN OPERATORS TO CLARIFY THE METHOD AND REQUIREMENT OF PRODUCT PACKAGING. 3) TRAIN INSPECTORS TO INCREASE THEIR QUALITY AWARENESS. IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION HAS BEEN UPDATED FROM THE INITIAL REPORT UPON COMPLETION OF THE INTERNAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO ABNORMAL ISSUE WAS FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS WAS COMPLIED WITH THE DMR. WE CHECKED RETENTION SAMPLES OF THIS BATCH, AND NO RELATED ISSUE WAS FOUND. DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER AND NO FIGURES WERE AVAILABLE, THE ROOT CAUSE ISN'T IDENTIFIED, THIS CASE IS DETERMINED AS AN ISOLATED ISSUE, AND WE WILL TRACE SIMILAR ISSUES.

    Description of Event or Problem · 0

    INVALID RESULT (S). I WAS TRYING TO USE A COVID TEST AND WHEN I OPENED THE BUFFER VIAL THERE WAS A WORM IN IT. AN ACTUAL WORM. MW5116548.

    Description of Event or Problem · 0

    INVALID RESULT (S). I WAS TRYING TO USE A COVID TEST AND WHEN I OPENED THE BUFFER VIAL THERE WAS A WORM IN IT. AN ACTUALWORM. MW5116548.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428972 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV2020172

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown