BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 18052322 · Received November 1, 2023

    Report

    Report Number
    2531491-2023-00719
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 1, 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

    THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM OUR CONTRACT MANUFACTURER, AND WE WILL PROVIDE FOLLOW UP MDR UPON INVESTIGATION COMPLETION SUCH AS REVIEW OF BATCH RECORDS OR TESTING OF RETENTION SAMPLES. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.

    Additional Manufacturer Narrative · 0

    BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR COV2010015 AND NO ABNORMAL ISSUE WAS FOUND IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS IS COMPLIED WITH DMR. THE TEST RESULTS OF RETENTION SAMPLES FROM COV2010015 CAN MEET THE QC CRITERIA. WE HAVE NOT FOUND THE COMPLAINT ISSUE FROM THE RETAINED CASSETTES. THE COMPLAINT IS NOT VERIFIED. IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION HAS BEEN UPDATED FROM THE INITIAL REPORT UPON COMPLETION OF THE INTERNAL INVESTIGATION.

    Description of Event or Problem · 0

    INVALID RESULT (S). CUSTOMER PURCHASED FLOWFLEX FROM HARRIS TEETER PHARMACY L031329-01 LOT COV2010015 WITH MANUFACTURE DATE OF 01/07/2022 AND EXPIRATION DATE OF 01/06/2023. TEST KIT DID NOT SHOW A CONTROL LINE AND THEREFORE STATED THAT KIT WAS DEFECTIVE AND UNSUABLE CREATING A LIFER/THREATENING CONDITION IF USED UNDER FDA APPROVED EXPIRATION DATE EXTENSION. CUSTOMER STATED THAT AN IMMEDIATE RECALL IS REQUIRED. MDR# MW5147163

    Description of Event or Problem · 0

    INVALID RESULT(S). CUSTOMER PURCHASED FLOWFLEX FROM (B)(6) L031329-01 LOT COV2010015 WITH MANUFACTURE DATE OF 01/07/2022 AND EXPIRATION DATE OF 01/06/2023. TEST KIT DID NOT SHOW A CONTROL LINE AND THEREFORE STATED THAT KIT WAS DEFECTIVE AND UNSUABLE CREATING A LIFER/THREATENING CONDITION IF USED UNDER FDA APPROVED EXPIRATION DATE EXTENSION. CUSTOMER STATED THAT AN IMMEDIATE RECALL IS REQUIRED. MDR# MW5147163.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851035 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV2010015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown